Injection Site IrritationNCT04673500
Assessment of Pain on Propofol Injection.
A study testing Propofol lidocaine through large vein and Propofol lidocaine through small vein in people with Injection Site Irritation, run by King Khalid University Hospital at 1 site in Saudi Arabia.
Trial summary
Title: Assessment of pain on lidocaine-Propofol admixture injection: Comparing large antecubital vein and small vein dorsum of hand. Objective: To evaluate the pain on Propofol - lidocaine admixture injection using different sizes of veins on upper limb. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Irritation
- What is being tested?
- Propofol lidocaine through large vein and Propofol lidocaine through small vein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20 to 50 years of either gender
- ASA ( American Society of Anesthesia) class 1 and 2
- Scheduled for elective surgical procedure under general anesthesia
Who cannot join
- Patients with known history of allergy to lidocaine or Propofol
- Obese patients
- Anticipated difficult intubation
- ASA 3 and 4
- Already on any analgesics and pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Large Antecubital Vein Versus Small Vein on Dorsum of Hand for the Prevention of Propofol Injection Pain
Title: Assessment of pain on lidocaine-Propofol admixture injection: Comparing large antecubital vein and small vein dorsum of hand.
- Objective: To evaluate the pain on Propofol - lidocaine admixture injection using different sizes of veins on upper limb.
- Design: Prospective randomized clinical trial Place and duration of study: Department of Anesthesia, King Saud University Riyadh May 1, 2013 - May 31, 2014).
- Patient and methods: Total 160 adult patients were divided in two groups. Age 20-50 years of either gender, American Society of Anesthesiologist (ASA) class 1 and 2, scheduled for elective surgery under general anesthesia were included in the study. Patients with known history of allergy to lidocaine or Propofol, obese patients, anticipated difficult intubation, already on any analgesics and pregnant patients were excluded from the study. Both groups received an admixture of Propofol (1%) - lidocaine (2%) on induction of anesthesia through antecubital vein (Group- 1) or through a vein on dorsum of hand (Group- 2). Pain was assessed as none, mild, moderate or severe. Results: Moderate to severe pain on intravenous injection of Propofol-lidocaine admixture through antecubital vein and small vein on dorsum of hand was 20% vs 71%. Conclusion: There is marked reduction of pain when Propofol - lidocaine admixture was injected through antecubital vein as compared to small vein on dorsum of hand.
- Key words: Propofol, injection, pain
Read the detailed description
Propofol is the most commonly used drug for induction of anesthesia because of its rapid onset, short duration of action, easy titration and with fewer hemodynamic Effects. Hypersensitivity reaction with Propofol is very rare and reported incidence of pain on injection is 26-70%. As Propofol is extensively used for the induction of anesthesia its pain on injection cannot be neglected. Propofol was launched for clinical practice in 1977 in Cremophor form and reformulation as aqueous solution was launched in 1986, an oil-in water emulsion containing soybean oil. Many interventions have been tried for the reduction of pain on Propofol aqueous solution injection. Unfortunately none of the intervention was found to be successful to abolish the pain completely. So far the mechanism of pain on Propofol injection is not clear.
The everyday uses of Propofol in many settings of the hospitals mandate its painless use. The proposed mechanisms of pain are release of local mediators and / or direct irritant effect of Propofol on nerve endings.
In this study the investigators combined two interventions, Propofol - lidocaine admixture and different size of veins, to evaluate the pain on Propofol injection. The admixture of Propofol-lidocaine was injected through two different sizes of veins which are commonly used for intravenous cannulations, large antecubital vein and small vein on dorsum of hand.
Propofol is a commonly used drug for induction of anesthesia and sedation in intensive care, emergency room and for endoscopic procedures. Unfortunately, despite its popularity pain on its injection is still unresolved problem. The exact mechanism of this pain is not clear so far.
Some investigators suggest that the lipid solvent for Propofol activates the plasma kallikrein-kinin system and produces bradykinin. This modifies the injected local vein causes vasodilation and hyper-permeability. This modification of the peripheral vein may increase the contact between the aqueous phase Propofol and free nerve endings of the vessel resulting in Pain.Others investigators believe that Propofol as a member of phenol group can have direct irritant effect on local vein by stimulating nociceptors and free nerve endings giving rise to an immediate sensation of pain. Based on these assumptions of Propofol induced pain pathway, different investigators postulated different interventions to alleviate this problem. Different pharmacological and non-pharmacological interventions have been tried for the reduction of pain on Propofol injection. The injection of Propofol through large antecubital vein was considered as a superior method than any other non pharmacology measures like changing the temperature of Propofol, large intravenous catheter and speed of injection.Pharmacological interventions with different drugs have been tried, pretreatment with lidocaine with venous occlusion. Propofol-lidocaine admixture, pretreatment with Ketamine, opioids,non-steroidal anti-inflammatory drugs ,magnesium sulfate, ondansetron, tramadol, acetaminophen, dexamethasone and Propofol emulsions containing medium and long chain triglycerides have been studied and reviewed extensively.
Among the all above interventions, Propofol lidocaine admixture is well known to be the best simple method. Lidocaine is a local anesthetic. It reduces the pain by two possible mechanisms, direct effect of local anesthetic on vascular smooth muscle and modifying the power of Hydrogen (pH) of Propofol. As lidocaine is a weak base solution when it dissolves with lipid it decrease the pH of the mixture. Thus, more Propofol in lipid phase cause less pain on injection.Injection of Propofol through large vein is another effective way in reducing pain. The vein diameter, flow rate, and endothelial structure might account for the reduction in pain. The injection of Propofol through a large antecubital vein, minimize the extent to which a high concentration of Propofol comes into contact with the sensitive endothelial wall. Furthermore Propofol will move faster from the injection site when more blood will be available to dissipate the bolus. Additionally, the composition of nociceptors along the endothelial wall might differ between the smaller veins of the hand and the larger antecubital veins. A meta-analysis showed that among the non-pharmacological and pharmacological interventions for the most effective method was the use of large antecubital vein followed by pretreatment with lidocaine combined with venous occlusion.
In this study the investigators have combined the two best and simple methods and compared the Propofol injection pain using two different sizes of veins on upper limb. The investigators have used small vein on dorsum of hand and large antecubital vein in the forearm. The investigators found that using large vein is superior to the small vein. Walker B.J. et al. reported that pretreatment with lidocaine using tourniquet is statistically superior to Propofol-lidocaine admixture. Whereas, Kim et al. investigated three doses of lidocaine mixed with Propofol 40 mg, 30 mg and 20 mg. The incidence of pain was 50%, 65% and 80% respectively.
In this study the investigators tested the efficacy of 20 milligram lidocaine in Propofol. When lidocaine -Propofol admixture was injected through small vein on dorsum of hand produces more pain as compared to large antecubital vein. This study results are comparable to the findings of Kim et al. However, combination of two strategies was unable to abolish Propofol injection pain completely. Based on these observations the investigators recommend whenever possible Propofol should be given in a mixture with lidocaine through large vein.
- Conditions
- Injection Site Irritation
- Being tested
- Propofol lidocaine through large vein, Propofol lidocaine through small vein
- Keywords
- Propofol, Injection pain, Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol lidocaine through large veinDrug
Also called Group I
A mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given through a large antecubital vein to assess pain severity on propofol injection during general anesthesia induction
Propofol lidocaine through small veinDrug
Also called Group II
A mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given through a small vein on the dorsum of hand to assess pain severity on propofol injection during general anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Propofol-lidocaine through large vein | Experimental | Eighty patients randomly assigned in this arm received a 20 gauge intravenous catheter at the antecubital fossa and a mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given for induction of general anesthesia. Receives: Drug: Propofol lidocaine through large vein |
| Propofol-lidocaine through small vein | Placebo comparator | Another eighty patients randomly assigned in this arm received a 20 gauge intravenous catheter at the dorsum of hand and a mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given for induction of general anesthesia. Receives: Drug: Propofol lidocaine through small vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of severity of pain on propofol injection
A 20 gauge intravenous catheter was inserted either in large antecubital vein or in a small vein on dorsum of hand. An initial 30% of a mixture of propofol lidocaine was given to assess the severity of pain on propofol injection before the patient sleeps. The pain on propofol injection was assessed by numerical rating scale (NRS).
0-10, where 0 is no pain and 10 is worst pain imaginable
Measured: From preoperative to day one postoperative
Secondary outcomes (1)
Heart rate
Heart rate was assessed in association with pain on propofol injection
Measured: From base line pre-propofol injection to Intraoperative after full dose of propofol injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Injection Site IrritationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized into two groups, eighty each. In all patients 15 to 30 minutes before shifting to the operation room a 20 gauge intravenous catheter was inserted either in a large antecubital vein (Group-1) or in a vein on dorsum of hand (Group-2). Lactate Ringer infusion was initiated at the rate of 120 ml/h. The arm was covered with green sheet. Patients received admixture of 2% lidocaine (1ml) in 1% propofol (19ml) either through large antecubital vein (Group-1, n = 80) or (Group-2, n = 80) through a vein at dorsum of hand. In both groups initially, thirty percent of the calculated dose of propofol (2mg/kg) was injected through an intravenous catheter. All patients were informed to report the researcher about the intensity of pain they experienced in numbers. Then induction of anesthesia was continued as routine.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khalid University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Sattar Narejo, King Khalid University Hospital
- Investigators
- Abdul Sattar Narejo, FCPS, FCAI, Principal investigator, King Khalid University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673500
- Sponsor's protocol ID
- KingKhalidUH
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2016
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. doi: 10.2174/1381612043382846.
PubMed 15579060Sim JY, Lee SH, Park DY, Jung JA, Ki KH, Lee DH, Noh GJ. Pain on injection with microemulsion propofol. Br J Clin Pharmacol. 2009 Mar;67(3):316-25. doi: 10.1111/j.1365-2125.2008.03358.x. Epub 2008 Dec 10.
PubMed 19220277Dubey PK, Kumar A. Pain on injection of lipid-free propofol and propofol emulsion containing medium-chain triglyceride: a comparative study. Anesth Analg. 2005 Oct;101(4):1060-1062. doi: 10.1213/01.ane.0000166951.72702.05.
PubMed 16192520Nakane M, Iwama H. A potential mechanism of propofol-induced pain on injection based on studies using nafamostat mesilate. Br J Anaesth. 1999 Sep;83(3):397-404. doi: 10.1093/bja/83.3.397.
PubMed 10655909Ambesh SP, Dubey PK, Sinha PK. Ondansetron pretreatment to alleviate pain on propofol injection: a randomized, controlled, double-blinded study. Anesth Analg. 1999 Jul;89(1):197-9. doi: 10.1097/00000539-199907000-00035.
PubMed 10389803Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.
PubMed 21406529Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.
PubMed 21455088Kim DH, Chae YJ, Chang HS, Kim JA, Joe HB. Intravenous lidocaine pretreatment with venous occlusion for reducing microemulsion propofol induced pain: comparison of three doses of lidocaine. J Int Med Res. 2014 Apr;42(2):368-75. doi: 10.1177/0300060513507391. Epub 2014 Mar 4.
PubMed 24595146Bano F, Zafar S, Sabbar S, Aftab S, Haider S, Sultan ST. Intravenous ketamine attenuates injection pain and arterial pressure changes during the induction of anesthesia with propofol: a comparison with lidocaine. J Coll Physicians Surg Pak. 2007 Jul;17(7):390-3.
PubMed 17686348Fujii Y, Itakura M. A comparison of pretreatment with fentanyl and lidocaine preceded by venous occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebo-controlled study in adult Japanese surgical patients. Clin Ther. 2009 Oct;31(10):2107-12. doi: 10.1016/j.clinthera.2009.10.012.
PubMed 19922881Alipour M, Tabari M, Alipour M. Paracetamol, ondansetron, granisetron, magnesium sulfate and lidocaine and reduced propofol injection pain. Iran Red Crescent Med J. 2014 Mar;16(3):e16086. doi: 10.5812/ircmj.16086. Epub 2014 Mar 5.
PubMed 24829787Rahimzadeh P, Faiz SH, Nikoobakht N, Ghodrati MR. Which one is more efficient on propofol 2% injection pain? Magnesium sulfate or ondansetron: A randomized clinical trial. Adv Biomed Res. 2015 Feb 17;4:56. doi: 10.4103/2277-9175.151593. eCollection 2015.
PubMed 25802825Borazan H, Sahin O, Kececioglu A, Uluer MS, Et T, Otelcioglu S. Prevention of propofol injection pain in children: a comparison of pretreatment with tramadol and propofol-lidocaine mixture. Int J Med Sci. 2012;9(6):492-7. doi: 10.7150/ijms.4793. Epub 2012 Aug 15.
PubMed 22927775Canbay O, Celebi N, Arun O, Karagoz AH, Saricaoglu F, Ozgen S. Efficacy of intravenous acetaminophen and lidocaine on propofol injection pain. Br J Anaesth. 2008 Jan;100(1):95-8. doi: 10.1093/bja/aem301. Epub 2007 Oct 23.
PubMed 17959585Ahmad S, De Oliveira GS Jr, Fitzgerald PC, McCarthy RJ. The effect of intravenous dexamethasone and lidocaine on propofol-induced vascular pain: a randomized double-blinded placebo-controlled trial. Pain Res Treat. 2013;2013:734531. doi: 10.1155/2013/734531. Epub 2013 Jul 15.
PubMed 23956857
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Large Antecubital Vein Versus Small Vein on Dorsum of Hand for the Prevention of Propofol Injection Pain
- ClinicalTrials.gov ID
- NCT04673500
- Acronym / sponsor ID
- KingKhalidUH
- Conditions
- Injection Site Irritation
- Keywords
- Propofol, Injection pain, Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- King Khalid University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: Assessment of pain on lidocaine-Propofol admixture injection: Comparing large antecubital vein and small vein dorsum of hand.
- Objective: To evaluate the pain on Propofol - lidocaine admixture injection using different sizes of veins on upper limb.
- Design: Prospective randomized clinical trial Place and duration of study: Department of Anesthesia, King Saud University Riyadh May 1, 2013 - May 31, 2014).
- Patient and methods: Total 160 adult patients were divided in two groups. Age 20-50 years of either gender, American Society of Anesthesiologist (ASA) class 1 and 2, scheduled for elective surgery under general anesthesia were included in the study. Patients with known history of allergy to lidocaine or Propofol, obese patients, anticipated difficult intubation, already on any analgesics and pregnant patients were excluded from the study. Both groups received an admixture of Propofol (1%) - lidocaine (2%) on induction of anesthesia through antecubital vein (Group- 1) or through a vein on dorsum of hand (Group- 2). Pain was assessed as none, mild, moderate or severe. Results: Moderate to severe pain on intravenous injection of Propofol-lidocaine admixture through antecubital vein and small vein on dorsum of hand was 20% vs 71%. Conclusion: There is marked reduction of pain when Propofol - lidocaine admixture was injected through antecubital vein as compared to small vein on dorsum of hand.
- Key words: Propofol, injection, pain
Detailed description
Propofol is the most commonly used drug for induction of anesthesia because of its rapid onset, short duration of action, easy titration and with fewer hemodynamic Effects. Hypersensitivity reaction with Propofol is very rare and reported incidence of pain on injection is 26-70%. As Propofol is extensively used for the induction of anesthesia its pain on injection cannot be neglected. Propofol was launched for clinical practice in 1977 in Cremophor form and reformulation as aqueous solution was launched in 1986, an oil-in water emulsion containing soybean oil. Many interventions have been tried for the reduction of pain on Propofol aqueous solution injection. Unfortunately none of the intervention was found to be successful to abolish the pain completely. So far the mechanism of pain on Propofol injection is not clear.
The everyday uses of Propofol in many settings of the hospitals mandate its painless use. The proposed mechanisms of pain are release of local mediators and / or direct irritant effect of Propofol on nerve endings.
In this study the investigators combined two interventions, Propofol - lidocaine admixture and different size of veins, to evaluate the pain on Propofol injection. The admixture of Propofol-lidocaine was injected through two different sizes of veins which are commonly used for intravenous cannulations, large antecubital vein and small vein on dorsum of hand.
Propofol is a commonly used drug for induction of anesthesia and sedation in intensive care, emergency room and for endoscopic procedures. Unfortunately, despite its popularity pain on its injection is still unresolved problem. The exact mechanism of this pain is not clear so far.
Some investigators suggest that the lipid solvent for Propofol activates the plasma kallikrein-kinin system and produces bradykinin. This modifies the injected local vein causes vasodilation and hyper-permeability. This modification of the peripheral vein may increase the contact between the aqueous phase Propofol and free nerve endings of the vessel resulting in Pain.Others investigators believe that Propofol as a member of phenol group can have direct irritant effect on local vein by stimulating nociceptors and free nerve endings giving rise to an immediate sensation of pain. Based on these assumptions of Propofol induced pain pathway, different investigators postulated different interventions to alleviate this problem. Different pharmacological and non-pharmacological interventions have been tried for the reduction of pain on Propofol injection. The injection of Propofol through large antecubital vein was considered as a superior method than any other non pharmacology measures like changing the temperature of Propofol, large intravenous catheter and speed of injection.Pharmacological interventions with different drugs have been tried, pretreatment with lidocaine with venous occlusion. Propofol-lidocaine admixture, pretreatment with Ketamine, opioids,non-steroidal anti-inflammatory drugs ,magnesium sulfate, ondansetron, tramadol, acetaminophen, dexamethasone and Propofol emulsions containing medium and long chain triglycerides have been studied and reviewed extensively.
Among the all above interventions, Propofol lidocaine admixture is well known to be the best simple method. Lidocaine is a local anesthetic. It reduces the pain by two possible mechanisms, direct effect of local anesthetic on vascular smooth muscle and modifying the power of Hydrogen (pH) of Propofol. As lidocaine is a weak base solution when it dissolves with lipid it decrease the pH of the mixture. Thus, more Propofol in lipid phase cause less pain on injection.Injection of Propofol through large vein is another effective way in reducing pain. The vein diameter, flow rate, and endothelial structure might account for the reduction in pain. The injection of Propofol through a large antecubital vein, minimize the extent to which a high concentration of Propofol comes into contact with the sensitive endothelial wall. Furthermore Propofol will move faster from the injection site when more blood will be available to dissipate the bolus. Additionally, the composition of nociceptors along the endothelial wall might differ between the smaller veins of the hand and the larger antecubital veins. A meta-analysis showed that among the non-pharmacological and pharmacological interventions for the most effective method was the use of large antecubital vein followed by pretreatment with lidocaine combined with venous occlusion.
In this study the investigators have combined the two best and simple methods and compared the Propofol injection pain using two different sizes of veins on upper limb. The investigators have used small vein on dorsum of hand and large antecubital vein in the forearm. The investigators found that using large vein is superior to the small vein. Walker B.J. et al. reported that pretreatment with lidocaine using tourniquet is statistically superior to Propofol-lidocaine admixture. Whereas, Kim et al. investigated three doses of lidocaine mixed with Propofol 40 mg, 30 mg and 20 mg. The incidence of pain was 50%, 65% and 80% respectively.
In this study the investigators tested the efficacy of 20 milligram lidocaine in Propofol. When lidocaine -Propofol admixture was injected through small vein on dorsum of hand produces more pain as compared to large antecubital vein. This study results are comparable to the findings of Kim et al. However, combination of two strategies was unable to abolish Propofol injection pain completely. Based on these observations the investigators recommend whenever possible Propofol should be given in a mixture with lidocaine through large vein.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomized into two groups, eighty each. In all patients 15 to 30 minutes before shifting to the operation room a 20 gauge intravenous catheter was inserted either in a large antecubital vein (Group-1) or in a vein on dorsum of hand (Group-2). Lactate Ringer infusion was initiated at the rate of 120 ml/h. The arm was covered with green sheet. Patients received admixture of 2% lidocaine (1ml) in 1% propofol (19ml) either through large antecubital vein (Group-1, n = 80) or (Group-2, n = 80) through a vein at dorsum of hand. In both groups initially, thirty percent of the calculated dose of propofol (2mg/kg) was injected through an intravenous catheter. All patients were informed to report the researcher about the intensity of pain they experienced in numbers. Then induction of anesthesia was continued as routine.
| Arm | Type | Receives |
|---|---|---|
| Propofol-lidocaine through large vein | Experimental | Drug: Propofol lidocaine through large veinEighty patients randomly assigned in this arm received a 20 gauge intravenous catheter at the antecubital fossa and a mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given for induction of general anesthesia. |
| Propofol-lidocaine through small vein | Placebo comparator | Drug: Propofol lidocaine through small veinAnother eighty patients randomly assigned in this arm received a 20 gauge intravenous catheter at the dorsum of hand and a mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given for induction of general anesthesia. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 20 to 50 years of either gender
- ASA ( American Society of Anesthesia) class 1 and 2
- Scheduled for elective surgical procedure under general anesthesia
Key exclusion criteria (5 listed)
- Patients with known history of allergy to lidocaine or Propofol
- Obese patients
- Anticipated difficult intubation
- ASA 3 and 4
- Already on any analgesics and pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol lidocaine through large veinAlso: Group IA mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given through a large antecubital vein to assess pain severity on propofol injection during general anesthesia induction | Drug | Propofol-lidocaine through large vein |
| Propofol lidocaine through small veinAlso: Group IIA mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given through a small vein on the dorsum of hand to assess pain severity on propofol injection during general anesthesia induction | Drug | Propofol-lidocaine through small vein |
Primary outcome
Assessment of severity of pain on propofol injection
Time frame: From preoperative to day one postoperative
A 20 gauge intravenous catheter was inserted either in large antecubital vein or in a small vein on dorsum of hand. An initial 30% of a mixture of propofol lidocaine was given to assess the severity of pain on propofol injection before the patient sleeps. The pain on propofol injection was assessed by numerical rating scale (NRS). 0-10, where 0 is no pain and 10 is worst pain imaginable
1 secondary outcome
Heart rate
Time frame: From base line pre-propofol injection to Intraoperative after full dose of propofol injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 15579060Marik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. doi: 10.2174/1381612043382846.
- Background: PubMed 19220277Sim JY, Lee SH, Park DY, Jung JA, Ki KH, Lee DH, Noh GJ. Pain on injection with microemulsion propofol. Br J Clin Pharmacol. 2009 Mar;67(3):316-25. doi: 10.1111/j.1365-2125.2008.03358.x. Epub 2008 Dec 10.
- Background: PubMed 16192520Dubey PK, Kumar A. Pain on injection of lipid-free propofol and propofol emulsion containing medium-chain triglyceride: a comparative study. Anesth Analg. 2005 Oct;101(4):1060-1062. doi: 10.1213/01.ane.0000166951.72702.05.
- Background: PubMed 10655909Nakane M, Iwama H. A potential mechanism of propofol-induced pain on injection based on studies using nafamostat mesilate. Br J Anaesth. 1999 Sep;83(3):397-404. doi: 10.1093/bja/83.3.397.
- Background: PubMed 10389803Ambesh SP, Dubey PK, Sinha PK. Ondansetron pretreatment to alleviate pain on propofol injection: a randomized, controlled, double-blinded study. Anesth Analg. 1999 Jul;89(1):197-9. doi: 10.1097/00000539-199907000-00035.
- Background: PubMed 21406529Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.
- Background: PubMed 21455088Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.
- Background: PubMed 24595146Kim DH, Chae YJ, Chang HS, Kim JA, Joe HB. Intravenous lidocaine pretreatment with venous occlusion for reducing microemulsion propofol induced pain: comparison of three doses of lidocaine. J Int Med Res. 2014 Apr;42(2):368-75. doi: 10.1177/0300060513507391. Epub 2014 Mar 4.
- Background: PubMed 17686348Bano F, Zafar S, Sabbar S, Aftab S, Haider S, Sultan ST. Intravenous ketamine attenuates injection pain and arterial pressure changes during the induction of anesthesia with propofol: a comparison with lidocaine. J Coll Physicians Surg Pak. 2007 Jul;17(7):390-3.
- Background: PubMed 19922881Fujii Y, Itakura M. A comparison of pretreatment with fentanyl and lidocaine preceded by venous occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebo-controlled study in adult Japanese surgical patients. Clin Ther. 2009 Oct;31(10):2107-12. doi: 10.1016/j.clinthera.2009.10.012.
- Background: PubMed 24829787Alipour M, Tabari M, Alipour M. Paracetamol, ondansetron, granisetron, magnesium sulfate and lidocaine and reduced propofol injection pain. Iran Red Crescent Med J. 2014 Mar;16(3):e16086. doi: 10.5812/ircmj.16086. Epub 2014 Mar 5.
- Background: PubMed 25802825Rahimzadeh P, Faiz SH, Nikoobakht N, Ghodrati MR. Which one is more efficient on propofol 2% injection pain? Magnesium sulfate or ondansetron: A randomized clinical trial. Adv Biomed Res. 2015 Feb 17;4:56. doi: 10.4103/2277-9175.151593. eCollection 2015.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Sattar Narejo, FCPS, FCAI principal investigator
King Khalid University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol lidocaine through large vein and Propofol lidocaine through small vein in people with Injection Site Irritation, run by King Khalid University Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of severity of pain on propofol injection (time frame: From preoperative to day one postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673500, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.