Efficacy of CPPLAI in Laparoscopic Sleeve Gastrectomy Patients (CPPLAI)

October 2, 2023 updated by: Abdul Sattar Narejo, King Khalid University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 7805/11472
        • King Khalid University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) physical status I-III
  • Age 18-60 years
  • Either gender
  • Obese patients (BMI >35 for laparoscopic sleeve gastrectomy

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPPLAI
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.
Procedure: 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.
Other Names:
  • Bupivacaine 0.25%
Drug: 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.
Other Names:
  • CPPLAI
Placebo Comparator: Placebo
Group 2 (placebo) (n= 58) will receive intraoperative combined periportal and preperitoneal sterile water 40 ml in patients scheduled for laparoscopic sleeve gastrectomy.
Other: Placebo
In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal 40 ml of sterile water.
Other Names:
  • Sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From preoperative to day two postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Morphine consumption
Time Frame: From preoperative to day two postoperative
Postoperative intravenous Morphine consumption in milligrams will be calculated as a total dose per patient that received to control pain after laparoscopic sleeve gastrectomy.
From preoperative to day two postoperative
Length of hospital stay
Time Frame: Through study completion, an average of 2 days.
Total number of days the patient stay in the hospital
Through study completion, an average of 2 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Khalid University Hospital

Investigators

  • Principal Investigator: Abdul Sattar Narejo, FCPS, King Khalid University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Actual)

June 7, 2021

Study Completion (Actual)

July 7, 2021

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project No. E-20-5332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After completing the data collection by July 2021, Pain score, opioid consumption, and length of hospital stay will be shared.

IPD Sharing Time Frame

December 2021

IPD Sharing Access Criteria

IPD (protocol, statistical analysis) will be shared on submitting requests through email to the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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