Obesity, MorbidCPPLAINCT04680923
Efficacy of CPPLAI in Laparoscopic Sleeve Gastrectomy Patients
A study testing CPPLAI and Bupivacaine 0.25% in people with Obesity, Morbid and Pain, Postoperative, run by King Khalid University Hospital at 1 site in Saudi Arabia.
Trial summary
The high demand for bariatric surgery due to the increasing prevalence of obesity worldwide necessitate evidence-based clinical pathway such as Enhanced Recovery After Bariatric Surgery (ERABS). The paradigm of surgery has been shifted from open to laparoscopic in morbidly obese patients. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Obesity, Morbid, Pain, Postoperative
- What is being tested?
- CPPLAI and Bupivacaine 0.25%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Dec 2020to 7 Jul 2021
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- American Society of Anesthesiologist (ASA) physical status I-III
- Age 18-60 years
- Either gender
- Obese patients (BMI >35 for laparoscopic sleeve gastrectomy
Who cannot join
- American Society of Anesthesiologist (ASA) physical status IV
- Patients uncontrolled HTN
- Anticipated difficult intubation
- Allergic to morphine
- Clinically significant neurological, cardiovascular, renal hepatic disease planned for postoperative surgical intensive care (SICU) admission
- History of drug abuse or chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combined Periportal and Preperitoneal Local Anesthetic Infiltration (CPPLAI) in Laparoscopic Sleeve Gastrectomy Patients
The high demand for bariatric surgery due to the increasing prevalence of obesity worldwide necessitate evidence-based clinical pathway such as Enhanced Recovery After Bariatric Surgery (ERABS). The paradigm of surgery has been shifted from open to laparoscopic in morbidly obese patients. Laparoscopic Sleeve Gastrectomy (LSG) is the most common procedure performed in our institute for sustained weight loss and amelioration of obesity-related comorbidities. Pain control in ERABS is one of the key factors for improved outcomes. Surgery induced acute postoperative pain, stress response and fatigue lead to prolonged convalescence and hospital stay. Optimal titrated safe postoperative pain management in LSG patients still remains a challenge.
Read the detailed description
Obesity is a complex multifactorial disease. The worldwide prevalence of obesity has doubled since 1980 to a level that now almost a third of the world's population is classified as overweight. Laparoscopic Sleeve Gastrectomy (LSG) is one of the effective treatments for sustained weight loss and to ameliorate the obesity-related comorbidities, and now the most commonly performed bariatric surgery worldwide. Postoperative pain from the laparoscopic portal sites and the visceral pain after gastrectomy requires a multimodal approach for pain management. As obese patients are sensitive to opioids overdose and at risk of respiratory depression and obstructive sleep apnoea, local anesthetic infiltration at the surgical incision sites and preperitoneal can decrease postoperative opioid consumption after LSG. Perioperative multimodal analgesia uses combinations of analgesic medications that act on different sites and pathways in an additive or synergistic manner to achieve pain relief with minimal or no opiate consumption. Although all medications have side effects, opiates have particularly concerning, multisystemic, long-term, and short-term side effects, which increase morbidity and prolong admissions. local infiltration analgesia (LIA) used widely as an effective component of multimodal analgesia and represents valuable options for controlling perioperative pain. LIA involves the injection and/or infusion of a local anesthetic near the site of surgical incision to provide targeted analgesia. A wide variety of techniques have been described, including single-injection intraoperative wound infiltration, indwelling wound infusion catheters, and the recent high-volume LIA technique associated with joint replacement surgery. Although, preperitoneal local anesthetic infiltration is a novel technique that was first described for pain relief after laparoscopic hernia repair. Recently, the investigators have used this technique in our institute during laparoscopic hernia repair which is now gaining popularity worldwide. Another investigator reported that continuous preperitoneal analgesia better attenuated postoperative inflammatory response and provided comparable overall analgesia to that with continuous epidural analgesia following radical cystectomy. Recently, a large systematic review and meta-analysis comparing preperitoneal or subcutaneous wound catheters with epidural analgesia in abdominal surgery showed preperitoneal wound catheters are an effective pain modality in abdominal surgery. Pain control was as effective as epidural analgesia and recovery parameters, opioid consumption, the incidence of hypotension, and patient satisfaction seemed to be in favor of preperitoneal wound catheters compared with active alternatives, as well as placebo. The trend for bariatric surgery is now moving towards opiates-almost free anesthesia. Since the first description of preperitoneal local anesthetic infiltration almost 2 decades ago little work has been done to test its efficacy, especially in LSG patients. The investigators of this study hypothesis that CPPLAI is an effective technique to reduce postoperative pain and favors early mobilization and patient satisfaction due to its fewer side effects.
- Conditions
- Obesity, Morbid, Pain, Postoperative
- Being tested
- CPPLAI, Placebo, Bupivacaine 0.25%
- Keywords
- Laparoscopic sleeve gastrectomy, post operative pain, local anesthetic infiltration, Periportal, Preperitoneal, Morbid obesity
- Medical subject headings
- Obesity, Morbid, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPPLAIProcedure or surgery
Also called Bupivacaine 0.25%
In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline.
PlaceboOther
Also called Sterile water
In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal 40 ml of sterile water.
Bupivacaine 0.25%Drug
Also called CPPLAI
In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline.
| Study group | Role | What they receive |
|---|---|---|
| CPPLAI | Experimental | Group-1 (CPPLAI) (n= 59) will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline in patients scheduled for laparoscopic sleeve gastrectomy. Receives: Procedure: CPPLAI; Drug: Bupivacaine 0.25% |
| Placebo | Placebo comparator | Group 2 (placebo) (n= 58) will receive intraoperative combined periportal and preperitoneal sterile water 40 ml in patients scheduled for laparoscopic sleeve gastrectomy. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain will be measured postoperatively using numerical rating scale (NRS) from 0 to 10 after laparoscopic sleeve gastrectomy. Where 0 is no pain and 10 is worst pain imaginable.
Measured: From preoperative to day two postoperative
Secondary outcomes (2)
Postoperative Morphine consumption
Postoperative intravenous Morphine consumption in milligrams will be calculated as a total dose per patient that received to control pain after laparoscopic sleeve gastrectomy.
Measured: From preoperative to day two postoperative
Length of hospital stay
Total number of days the patient stay in the hospital
Measured: Through study completion, an average of 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start8 Dec 2020
- Primary completion7 Jun 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- 117 adult patients scheduled for Laparoscopic Sleeve Gastrectomy (LSG) will be recruited in this prospective clinical study. The patients will be divided into two groups; group-1 (CPPLAI) (n= 59) will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline and group 2 (placebo) (n= 58) periportal and preperitoneal 40 ml of sterile water will be injected.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 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, Principal investigator, King Khalid University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680923
- Sponsor's protocol ID
- Project No. E-20-5332
- Acronym
- CPPLAI
- Status last verified
- Oct 2023
- First submitted
- 8 Dec 2020
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completing the data collection by July 2021, Pain score, opioid consumption, and length of hospital stay will be shared.
Publications
Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
PubMed 30253139Chung AY, Thompson R, Overby DW, Duke MC, Farrell TM. Sleeve Gastrectomy: Surgical Tips. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):930-937. doi: 10.1089/lap.2018.0392. Epub 2018 Jul 13.
PubMed 30004814Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3.
PubMed 31256367Boerboom SL, de Haes A, Vd Wetering L, Aarts EO, Janssen IMC, Geurts JW, Kamphuis ET. Preperitoneal Bupivacaine Infiltration Reduces Postoperative Opioid Consumption, Acute Pain, and Chronic Postsurgical Pain After Bariatric Surgery: a Randomized Controlled Trial. Obes Surg. 2018 Oct;28(10):3102-3110. doi: 10.1007/s11695-018-3341-6.
PubMed 29926357Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018.
PubMed 28526156Merritt CK, Mariano ER, Kaye AD, Lissauer J, Mancuso K, Prabhakar A, Urman RD. Peripheral nerve catheters and local anesthetic infiltration in perioperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):41-57. doi: 10.1016/j.bpa.2014.02.002. Epub 2014 Mar 18.
PubMed 24815966Joshi GP, Machi A. Surgical site infiltration: A neuroanatomical approach. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):317-324. doi: 10.1016/j.bpa.2019.07.017. Epub 2019 Jul 25.
PubMed 31785717Deans GT, Wilson MS, Brough WA. Controlled trial of preperitoneal local anaesthetic for reducing pain following laparoscopic hernia repair. Br J Surg. 1998 Jul;85(7):1013-4. doi: 10.1046/j.1365-2168.1998.00763.x.
PubMed 9692587Aldohayan A, Eldawlatly A. Combined preincisional periportal and preperitoneal infiltration with bupivacaine in pain relief after laparoscopic surgery. Saudi J Anaesth. 2017 Apr-Jun;11(2):135-136. doi: 10.4103/sja.SJA_153_17. No abstract available.
PubMed 28442949Othman AH, Ahmed DG, Abd El-Rahman AM, El Sherif FA, Mansour S, Aboeleuon E. Effect of Preperitoneal Versus Epidural Analgesia on Postoperative Inflammatory Response and Pain Following Radical Cystectomy: A Prospective, Randomized Trial. Clin J Pain. 2019 Apr;35(4):328-334. doi: 10.1097/AJP.0000000000000679.
PubMed 30829734Mungroop TH, Bond MJ, Lirk P, Busch OR, Hollmann MW, Veelo DP, Besselink MG. Preperitoneal or Subcutaneous Wound Catheters as Alternative for Epidural Analgesia in Abdominal Surgery: A Systematic Review and Meta-analysis. Ann Surg. 2019 Feb;269(2):252-260. doi: 10.1097/SLA.0000000000002817.
PubMed 29781846Lirk P, Rathmell JP. Opioid-free anaesthesia: Con: it is too early to adopt opioid-free anaesthesia today. Eur J Anaesthesiol. 2019 Apr;36(4):250-254. doi: 10.1097/EJA.0000000000000965. No abstract available.
PubMed 30817360
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Periportal and Preperitoneal Local Anesthetic Infiltration (CPPLAI) in Laparoscopic Sleeve Gastrectomy Patients
- ClinicalTrials.gov ID
- NCT04680923
- Acronym / sponsor ID
- CPPLAI / Project No. E-20-5332
- Conditions
- Obesity, Morbid, Pain, Postoperative
- Keywords
- Laparoscopic sleeve gastrectomy, post operative pain, local anesthetic infiltration, Periportal, Preperitoneal, Morbid obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- King Khalid University HospitalUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 23 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.
The high demand for bariatric surgery due to the increasing prevalence of obesity worldwide necessitate evidence-based clinical pathway such as Enhanced Recovery After Bariatric Surgery (ERABS). The paradigm of surgery has been shifted from open to laparoscopic in morbidly obese patients. Laparoscopic Sleeve Gastrectomy (LSG) is the most common procedure performed in our institute for sustained weight loss and amelioration of obesity-related comorbidities. Pain control in ERABS is one of the key factors for improved outcomes. Surgery induced acute postoperative pain, stress response and fatigue lead to prolonged convalescence and hospital stay. Optimal titrated safe postoperative pain management in LSG patients still remains a challenge.
Detailed description
Obesity is a complex multifactorial disease. The worldwide prevalence of obesity has doubled since 1980 to a level that now almost a third of the world's population is classified as overweight. Laparoscopic Sleeve Gastrectomy (LSG) is one of the effective treatments for sustained weight loss and to ameliorate the obesity-related comorbidities, and now the most commonly performed bariatric surgery worldwide. Postoperative pain from the laparoscopic portal sites and the visceral pain after gastrectomy requires a multimodal approach for pain management. As obese patients are sensitive to opioids overdose and at risk of respiratory depression and obstructive sleep apnoea, local anesthetic infiltration at the surgical incision sites and preperitoneal can decrease postoperative opioid consumption after LSG. Perioperative multimodal analgesia uses combinations of analgesic medications that act on different sites and pathways in an additive or synergistic manner to achieve pain relief with minimal or no opiate consumption. Although all medications have side effects, opiates have particularly concerning, multisystemic, long-term, and short-term side effects, which increase morbidity and prolong admissions. local infiltration analgesia (LIA) used widely as an effective component of multimodal analgesia and represents valuable options for controlling perioperative pain. LIA involves the injection and/or infusion of a local anesthetic near the site of surgical incision to provide targeted analgesia. A wide variety of techniques have been described, including single-injection intraoperative wound infiltration, indwelling wound infusion catheters, and the recent high-volume LIA technique associated with joint replacement surgery. Although, preperitoneal local anesthetic infiltration is a novel technique that was first described for pain relief after laparoscopic hernia repair. Recently, the investigators have used this technique in our institute during laparoscopic hernia repair which is now gaining popularity worldwide. Another investigator reported that continuous preperitoneal analgesia better attenuated postoperative inflammatory response and provided comparable overall analgesia to that with continuous epidural analgesia following radical cystectomy. Recently, a large systematic review and meta-analysis comparing preperitoneal or subcutaneous wound catheters with epidural analgesia in abdominal surgery showed preperitoneal wound catheters are an effective pain modality in abdominal surgery. Pain control was as effective as epidural analgesia and recovery parameters, opioid consumption, the incidence of hypotension, and patient satisfaction seemed to be in favor of preperitoneal wound catheters compared with active alternatives, as well as placebo. The trend for bariatric surgery is now moving towards opiates-almost free anesthesia. Since the first description of preperitoneal local anesthetic infiltration almost 2 decades ago little work has been done to test its efficacy, especially in LSG patients. The investigators of this study hypothesis that CPPLAI is an effective technique to reduce postoperative pain and favors early mobilization and patient satisfaction due to its fewer side effects.
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
- 117 adult patients scheduled for Laparoscopic Sleeve Gastrectomy (LSG) will be recruited in this prospective clinical study. The patients will be divided into two groups; group-1 (CPPLAI) (n= 59) will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline and group 2 (placebo) (n= 58) periportal and preperitoneal 40 ml of sterile water will be injected.
| Arm | Type | Receives |
|---|---|---|
| CPPLAI | Experimental | Procedure: CPPLAI, Drug: Bupivacaine 0.25%Group-1 (CPPLAI) (n= 59) will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline in patients scheduled for laparoscopic sleeve gastrectomy. |
| Placebo | Placebo comparator | Other: PlaceboGroup 2 (placebo) (n= 58) will receive intraoperative combined periportal and preperitoneal sterile water 40 ml in patients scheduled for laparoscopic sleeve gastrectomy. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologist (ASA) physical status I-III
- Age 18-60 years
- Either gender
- Obese patients (BMI >35 for laparoscopic sleeve gastrectomy
Key exclusion criteria (6 listed)
- American Society of Anesthesiologist (ASA) physical status IV
- Patients uncontrolled HTN
- Anticipated difficult intubation
- Allergic to morphine
- Clinically significant neurological, cardiovascular, renal hepatic disease planned for postoperative surgical intensive care (SICU) admission
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 |
|---|---|---|
| CPPLAIAlso: Bupivacaine 0.25%In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline. | Procedure or surgery | CPPLAI |
| PlaceboAlso: Sterile waterIn this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal 40 ml of sterile water. | Other | Placebo |
| Bupivacaine 0.25%Also: CPPLAIIn this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline. | Drug | CPPLAI |
Primary outcome
Postoperative pain
Time frame: From preoperative to day two postoperative
Pain will be measured postoperatively using numerical rating scale (NRS) from 0 to 10 after laparoscopic sleeve gastrectomy. Where 0 is no pain and 10 is worst pain imaginable.
2 secondary outcomes
Postoperative Morphine consumption
Time frame: From preoperative to day two postoperative
Length of hospital stay
Time frame: Through study completion, an average of 2 days.
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 3 Oct 2023.
- Background: PubMed 30253139Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
- Background: PubMed 30004814Chung AY, Thompson R, Overby DW, Duke MC, Farrell TM. Sleeve Gastrectomy: Surgical Tips. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):930-937. doi: 10.1089/lap.2018.0392. Epub 2018 Jul 13.
- Background: PubMed 31256367Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3.
- Background: PubMed 29926357Boerboom SL, de Haes A, Vd Wetering L, Aarts EO, Janssen IMC, Geurts JW, Kamphuis ET. Preperitoneal Bupivacaine Infiltration Reduces Postoperative Opioid Consumption, Acute Pain, and Chronic Postsurgical Pain After Bariatric Surgery: a Randomized Controlled Trial. Obes Surg. 2018 Oct;28(10):3102-3110. doi: 10.1007/s11695-018-3341-6.
- Background: PubMed 28526156Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018.
- Background: PubMed 24815966Merritt CK, Mariano ER, Kaye AD, Lissauer J, Mancuso K, Prabhakar A, Urman RD. Peripheral nerve catheters and local anesthetic infiltration in perioperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):41-57. doi: 10.1016/j.bpa.2014.02.002. Epub 2014 Mar 18.
- Background: PubMed 31785717Joshi GP, Machi A. Surgical site infiltration: A neuroanatomical approach. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):317-324. doi: 10.1016/j.bpa.2019.07.017. Epub 2019 Jul 25.
- Background: PubMed 9692587Deans GT, Wilson MS, Brough WA. Controlled trial of preperitoneal local anaesthetic for reducing pain following laparoscopic hernia repair. Br J Surg. 1998 Jul;85(7):1013-4. doi: 10.1046/j.1365-2168.1998.00763.x.
- Background: PubMed 28442949Aldohayan A, Eldawlatly A. Combined preincisional periportal and preperitoneal infiltration with bupivacaine in pain relief after laparoscopic surgery. Saudi J Anaesth. 2017 Apr-Jun;11(2):135-136. doi: 10.4103/sja.SJA_153_17. No abstract available.
- Background: PubMed 30829734Othman AH, Ahmed DG, Abd El-Rahman AM, El Sherif FA, Mansour S, Aboeleuon E. Effect of Preperitoneal Versus Epidural Analgesia on Postoperative Inflammatory Response and Pain Following Radical Cystectomy: A Prospective, Randomized Trial. Clin J Pain. 2019 Apr;35(4):328-334. doi: 10.1097/AJP.0000000000000679.
- Background: PubMed 29781846Mungroop TH, Bond MJ, Lirk P, Busch OR, Hollmann MW, Veelo DP, Besselink MG. Preperitoneal or Subcutaneous Wound Catheters as Alternative for Epidural Analgesia in Abdominal Surgery: A Systematic Review and Meta-analysis. Ann Surg. 2019 Feb;269(2):252-260. doi: 10.1097/SLA.0000000000002817.
- Background: PubMed 30817360Lirk P, Rathmell JP. Opioid-free anaesthesia: Con: it is too early to adopt opioid-free anaesthesia today. Eur J Anaesthesiol. 2019 Apr;36(4):250-254. doi: 10.1097/EJA.0000000000000965. No abstract available.
- Individual participant dataSharing planned: Yes. After completing the data collection by July 2021, Pain score, opioid consumption, and length of hospital stay will be shared.
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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.
Abdul Sattar Narejo, FCPS 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 CPPLAI and Bupivacaine 0.25% in people with Obesity, Morbid and Pain, Postoperative, 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 4 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 3 Oct 2023. 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?
Postoperative pain (time frame: From preoperative to day two 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 NCT04680923, which also lists 12 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 3 Oct 2023.