Efficacy of CPPLAI in Laparoscopic Sleeve Gastrectomy Patients

NCT ID: NCT04680923

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2021-07-07

Brief 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. 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.

Conditions

Obesity, Morbid; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

CPPLAI

Intervention Type: PROCEDURE

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.

Bupivacaine 0.25%

Intervention Type: DRUG

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.

Placebo

Group 2 (placebo) (n= 58) will receive intraoperative combined periportal and preperitoneal sterile water 40 ml in patients scheduled for laparoscopic sleeve gastrectomy.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal 40 ml of sterile water.

Interventions

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.

Intervention Type: PROCEDURE

Placebo

In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal 40 ml of sterile water.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine 0.25%; Sterile water; CPPLAI

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Khalid University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Abdul Sattar Narejo

Consultant Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdul Sattar Narejo, FCPS

Role: PRINCIPAL_INVESTIGATOR

King Khalid University Hospital

Locations

King Khalid University Hospital

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

References

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Reference Type: BACKGROUND

PMID: 30253139 (View on PubMed)

Chung 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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 31256367 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 9692587 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

Project No. E-20-5332

Identifier Type: -

Identifier Source: org_study_id