Cholecystectomy, LaparoscopicNCT06605235
The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy
A study testing Local Anesthesia in people with Cholecystectomy, Laparoscopic and Pain Management, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
Trial summary
To control pain after surgery for removal of gallbladder, local anesthetic agent can be sprayed on the liver bed from where the gallbladder is removed. This study was conducted to identify the ideal local anesthetic agent for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Pain Management
- What is being tested?
- Local Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective/emergency laparoscopic cholecystectomy
- ASA grade I/II
- Ages 18-75 years
Who cannot join
- patients on chronic analgesics
- pts receiving analgesics 24 hours prior to surgery
- intraoperative bile spillage or drain placement
- CBD exploration or T-tube insertion
- BMI \> 40 kg/m2
- pts allergic to, or otherwise not able to receive medications being tested
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy - a Randomized Controlled Trial
To control pain after surgery for removal of gallbladder, local anesthetic agent can be sprayed on the liver bed from where the gallbladder is removed. This study was conducted to identify the ideal local anesthetic agent for this purpose.
Read the detailed description
Laparoscopic cholecystectomy is the gold standard operation for symptomatic cholelithiasis; however, pain remains a major factor increasing morbidity and length of hospital stay. Infiltration of gallbladder bed with local anesthetic has been shown to improve post-operative pain after laparoscopic cholecystectomy, although, it is unclear which local anesthetic provides superior pain relief. Patients undergoing laparoscopic cholecystectomies were randomized into 3 groups of 30 patients each depending on the local anesthetic instilled in the gallbladder bed; lignocaine (Group A), bupivacaine (Group B), or a combination of lignocaine and bupivacaine (Group C). Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery
- Conditions
- Cholecystectomy, Laparoscopic, Pain Management
- Being tested
- Local Anesthesia
- Keywords
- laparoscopic cholecystectomy, lignocaine, bupivacaine, visual analogue scale
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local AnesthesiaProcedure or surgery
In Group A, patients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure. Subjects in Group B received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites. In Group C patients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites
| Study group | Role | What they receive |
|---|---|---|
| Lignocaine | Experimental | patients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure Receives: Procedure: Local Anesthesia |
| Bupivacaine | Experimental | Subjects received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites Receives: Procedure: Local Anesthesia |
| Lignocaine + Bupivacaine | Experimental | patients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites Receives: Procedure: Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale - pain score
Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).
Measured: 2-, 6-, 12-, 24-hours following surgery
Secondary outcomes (8)
Shoulder tip pain
The time following surgery when shoulder tip pain was gone
Measured: within 24 hours following surgery
Flatus
Time to passing flatus
Measured: within 24 hours following surgery
nausea/vomiting
time when nausea/vomiting was not present in the patient
Measured: within 24 hours following surgery
Time to ambulation
time after surgery when the patient started ambulating
Measured: within 24 hours following surgery
rescue analgesia
number of times rescue analgesia was used
Measured: within 24 hours following surgery
Mean arterial pressure
systolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated
Measured: 2-, 6-, 12-, 24-hours following surgery
Heart rate
Heart rate was measured at intervals in beats per minute
Measured: 2-, 6-, 12-, 24 hours
oxygen saturation
oxygen saturation was noted at intervals
Measured: 2-, 6-, 12-, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jan 2024
- Primary completion28 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Air Force (PAF) Hospital Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Moiz Ahmed, Pakistan Air Force (PAF) Hospital Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605235
- Sponsor's protocol ID
- SGR-2021-137-2499-1
- Other IDs
- SGR-2021-137-2499-1
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeh CN, Tsai CY, Cheng CT, Wang SY, Liu YY, Chiang KC, Hsieh FJ, Lin CC, Jan YY, Chen MF. Pain relief from combined wound and intraperitoneal local anesthesia for patients who undergo laparoscopic cholecystectomy. BMC Surg. 2014 May 12;14:28. doi: 10.1186/1471-2482-14-28.
PubMed 24886449Protic M, Veljkovic R, Bilchik AJ, Popovic A, Kresoja M, Nissan A, Avital I, Stojadinovic A. Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy. Surg Endosc. 2017 Feb;31(2):704-713. doi: 10.1007/s00464-016-5024-5. Epub 2016 Jun 20.
PubMed 27324337Inan A, Sen M, Dener C. Local anesthesia use for laparoscopic cholecystectomy. World J Surg. 2004 Aug;28(8):741-4. doi: 10.1007/s00268-004-7350-3. Epub 2004 Aug 3.
PubMed 15457350Donatsky AM, Bjerrum F, Gogenur I. Intraperitoneal instillation of saline and local anesthesia for prevention of shoulder pain after laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2013 Jul;27(7):2283-92. doi: 10.1007/s00464-012-2760-z. Epub 2013 Jan 26.
PubMed 23355159Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg. 2006 Sep;103(3):682-8. doi: 10.1213/01.ane.0000226268.06279.5a.
PubMed 16931681Ejlersen E, Andersen HB, Eliasen K, Mogensen T. A comparison between preincisional and postincisional lidocaine infiltration and postoperative pain. Anesth Analg. 1992 Apr;74(4):495-8. doi: 10.1213/00000539-199204000-00004.
PubMed 1482431Ng A, Swami A, Smith G, Robertson G, Lloyd DM. Is intraperitoneal levobupivacaine with epinephrine useful for analgesia following laparoscopic cholecystectomy? A randomized controlled trial. Eur J Anaesthesiol. 2004 Aug;21(8):653-7. doi: 10.1017/s0265021504008117.
PubMed 15473621Rutherford D, Massie EM, Worsley C, Wilson MS. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD007337. doi: 10.1002/14651858.CD007337.pub4.
PubMed 34693999Strasberg SM, Clavien PA. Overview of therapeutic modalities for the treatment of gallstone diseases. Am J Surg. 1993 Apr;165(4):420-6. doi: 10.1016/s0002-9610(05)80933-x.
PubMed 8480874Rance, G. and A. Jones, Gallstone disease. InnovAiT, 2016. 9(1): p. 7.
Stinton LM, Myers RP, Shaffer EA. Epidemiology of gallstones. Gastroenterol Clin North Am. 2010 Jun;39(2):157-69, vii. doi: 10.1016/j.gtc.2010.02.003.
PubMed 20478480
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06605235
- Acronym / sponsor ID
- SGR-2021-137-2499-1
- Conditions
- Cholecystectomy, Laparoscopic, Pain Management
- Keywords
- laparoscopic cholecystectomy, lignocaine, bupivacaine, visual analogue scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pakistan Air Force (PAF) Hospital IslamabadUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Sep 2024 (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.
To control pain after surgery for removal of gallbladder, local anesthetic agent can be sprayed on the liver bed from where the gallbladder is removed. This study was conducted to identify the ideal local anesthetic agent for this purpose.
Detailed description
Laparoscopic cholecystectomy is the gold standard operation for symptomatic cholelithiasis; however, pain remains a major factor increasing morbidity and length of hospital stay. Infiltration of gallbladder bed with local anesthetic has been shown to improve post-operative pain after laparoscopic cholecystectomy, although, it is unclear which local anesthetic provides superior pain relief. Patients undergoing laparoscopic cholecystectomies were randomized into 3 groups of 30 patients each depending on the local anesthetic instilled in the gallbladder bed; lignocaine (Group A), bupivacaine (Group B), or a combination of lignocaine and bupivacaine (Group C). Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lignocaine | Experimental | Procedure: Local Anesthesiapatients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure |
| Bupivacaine | Experimental | Procedure: Local AnesthesiaSubjects received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites |
| Lignocaine + Bupivacaine | Experimental | Procedure: Local Anesthesiapatients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective/emergency laparoscopic cholecystectomy
- ASA grade I/II
- Ages 18-75 years
Key exclusion criteria (6 listed)
- patients on chronic analgesics
- pts receiving analgesics 24 hours prior to surgery
- intraoperative bile spillage or drain placement
- CBD exploration or T-tube insertion
- BMI \> 40 kg/m2
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 |
|---|---|---|
| Local AnesthesiaIn Group A, patients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure. Subjects in Group B received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites. In Group C patients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites | Procedure or surgery | Bupivacaine, Lignocaine, Lignocaine + Bupivacaine |
Primary outcome
Visual analogue scale - pain score
Time frame: 2-, 6-, 12-, 24-hours following surgery
Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).
8 secondary outcomes
Shoulder tip pain
Time frame: within 24 hours following surgery
Flatus
Time frame: within 24 hours following surgery
nausea/vomiting
Time frame: within 24 hours following surgery
Time to ambulation
Time frame: within 24 hours following surgery
rescue analgesia
Time frame: within 24 hours following surgery
Mean arterial pressure
Time frame: 2-, 6-, 12-, 24-hours following surgery
Heart rate
Time frame: 2-, 6-, 12-, 24 hours
oxygen saturation
Time frame: 2-, 6-, 12-, 24 hours
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 20 Sep 2024.
- Background: PubMed 24886449Yeh CN, Tsai CY, Cheng CT, Wang SY, Liu YY, Chiang KC, Hsieh FJ, Lin CC, Jan YY, Chen MF. Pain relief from combined wound and intraperitoneal local anesthesia for patients who undergo laparoscopic cholecystectomy. BMC Surg. 2014 May 12;14:28. doi: 10.1186/1471-2482-14-28.
- Background: PubMed 27324337Protic M, Veljkovic R, Bilchik AJ, Popovic A, Kresoja M, Nissan A, Avital I, Stojadinovic A. Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy. Surg Endosc. 2017 Feb;31(2):704-713. doi: 10.1007/s00464-016-5024-5. Epub 2016 Jun 20.
- Background: PubMed 15457350Inan A, Sen M, Dener C. Local anesthesia use for laparoscopic cholecystectomy. World J Surg. 2004 Aug;28(8):741-4. doi: 10.1007/s00268-004-7350-3. Epub 2004 Aug 3.
- Background: PubMed 23355159Donatsky AM, Bjerrum F, Gogenur I. Intraperitoneal instillation of saline and local anesthesia for prevention of shoulder pain after laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2013 Jul;27(7):2283-92. doi: 10.1007/s00464-012-2760-z. Epub 2013 Jan 26.
- Background: PubMed 16931681Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg. 2006 Sep;103(3):682-8. doi: 10.1213/01.ane.0000226268.06279.5a.
- Background: PubMed 1482431Ejlersen E, Andersen HB, Eliasen K, Mogensen T. A comparison between preincisional and postincisional lidocaine infiltration and postoperative pain. Anesth Analg. 1992 Apr;74(4):495-8. doi: 10.1213/00000539-199204000-00004.
- Background: PubMed 15473621Ng A, Swami A, Smith G, Robertson G, Lloyd DM. Is intraperitoneal levobupivacaine with epinephrine useful for analgesia following laparoscopic cholecystectomy? A randomized controlled trial. Eur J Anaesthesiol. 2004 Aug;21(8):653-7. doi: 10.1017/s0265021504008117.
- Background: PubMed 34693999Rutherford D, Massie EM, Worsley C, Wilson MS. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD007337. doi: 10.1002/14651858.CD007337.pub4.
- Background: PubMed 8480874Strasberg SM, Clavien PA. Overview of therapeutic modalities for the treatment of gallstone diseases. Am J Surg. 1993 Apr;165(4):420-6. doi: 10.1016/s0002-9610(05)80933-x.
- BackgroundRance, G. and A. Jones, Gallstone disease. InnovAiT, 2016. 9(1): p. 7.
- Background: PubMed 20478480Stinton LM, Myers RP, Shaffer EA. Epidemiology of gallstones. Gastroenterol Clin North Am. 2010 Jun;39(2):157-69, vii. doi: 10.1016/j.gtc.2010.02.003.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Anesthesia in people with Cholecystectomy, Laparoscopic and Pain Management, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
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 6 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 20 Sep 2024. 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 Pakistan. 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. 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?
Visual analogue scale - pain score (time frame: 2-, 6-, 12-, 24-hours following surgery). 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 NCT06605235, which also lists 11 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 20 Sep 2024.