Efficacy of CPPLAI in Laparoscopic Sleeve Gastrectomy Patients

NCT04680923 | Completed

• 1 other identifier: Project No. E-20-5332
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Pain, Postoperative

Keywords

Laparoscopic sleeve gastrectomy; post operative pain; local anesthetic infiltration; Periportal; Preperitoneal; Morbid obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  From preoperative to day two postoperative

Secondary Outcomes (2)

• Postoperative Morphine consumption

  From preoperative to day two postoperative

• Length of hospital stay

  Through study completion, an average of 2 days.

Study Arms (2)

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.

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.

Other: Placebo

Interventions

CPPLAI 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.

Also known as: Bupivacaine 0.25%

CPPLAI

Placebo OTHER

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

Also known as: Sterile water

Placebo

Bupivacaine 0.25% 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.

Also known as: CPPLAI

CPPLAI

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Khalid University Hospital: lead

Study Sites (1)

King Khalid University Hospital

Riyadh, 7805/11472, Saudi Arabia

Location

Related Publications (12)

• 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.

  PMID: 30253139 BACKGROUND

• 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.

  PMID: 30004814 BACKGROUND

• Belcaid I, Eipe N. Perioperative Pain Management in Morbid Obesity. Drugs. 2019 Jul;79(11):1163-1175. doi: 10.1007/s40265-019-01156-3.

  PMID: 31256367 BACKGROUND

• Boerboom 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.

  PMID: 29926357 BACKGROUND

• Beverly 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.

  PMID: 28526156 BACKGROUND

• Merritt 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.

  PMID: 24815966 BACKGROUND

• Joshi 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.

  PMID: 31785717 BACKGROUND

• Deans 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.

  PMID: 9692587 BACKGROUND

• Aldohayan 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.

  PMID: 28442949 BACKGROUND

• Othman 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.

  PMID: 30829734 BACKGROUND

• Mungroop 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.

  PMID: 29781846 BACKGROUND

• Lirk 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.

  PMID: 30817360 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Pain, Postoperative

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• Abdul Sattar Narejo, FCPS

  King Khalid University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All patients, care providers in PACU \& ward (nurses), and outcome assessors (assistant anesthesiologist) will be blinded to the group allocation. Only the assigned anesthesiologist responsible for perioperative care and the surgeon performing preperitoneal local anesthetic infiltration will be aware of the group allocation to treat any unwanted side effects during and after the operation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 23, 2020
• Study Start: December 8, 2020
• Primary Completion: June 7, 2021
• Study Completion: July 7, 2021
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: December 2021
• Access Criteria: IPD (protocol, statistical analysis) will be shared on submitting requests through email to the principal investigator.

Locations

SA (1)