Analgesia After Laparoscopic Cholecystectomy

Comparison of Subcostal Transversus Abdominis Block With Intraperitoneal Instillation of Bupivacaine and Dexmedetomidine for Pain Relief After Laparoscopic Cholecystectomy: A Randomized Trial

Pain after laparoscopic cholecystectomy is common and may lead to delayed hospital discharge.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: USG-STAP with bupivacaine and dexmedetomidine; Drug: IP bupivacaine and dexmedetomidine

Detailed Description

Laparoscopic cholecystectomy (LC) is very commonly performed nowadays, and it has now completely replaced open cholecystectomy in the management of biliary lithiasis. Although it is minimally invasive surgery, pain in postoperative period is always major concern as it increases perioperative stress, morbidity, and hospital stay.

There are two components involved in pain after LC; the visceral component is due to tissue damage in anterior abdominal wall during the insertion of trocar and shoulder tip pain due to diaphragmatic irritation caused by Spillage of blood or bile and peritoneum stretching caused by pneumoperitoneum.

There are several methods employed in the management of postoperative pain after LC such as conventional systemic analgesics, including paracetamol, non-steroidal anti-inflammatory drugs, systemic opioids, thoracic epidural analgesia, low-pressure pneumoperitoneum, and warm air with all having its side effects .

Transversus abdominis plane (TAP) block has got a substantial role in postoperative analgesia after abdominal surgery because deposition of local anesthetics in transversus abdominis fascial plane can produce sensory block over the anterior abdominal wall from T7 to L1. Many clinical studies reported beneficial effects of TAP but results were mainly connected to lower abdominal surgery. Since the major part of pain after LC derives from abdominal wall incisions, some trials investigated TAP block as potential analgesic option. Some studies showed that TAP block can reduce opioid requirements and pain scores but the results were not conclusive enough because many differences in study designs.

The ultrasound-guided (USG) subcostal transversus abdominis plane block (STAP), first described by Hebbard 2008, is a variation of TAP which successfully solve the problem of unreliable supraumbilical distribution of the block. Results obtained in a few small studies showed significantly better analgesia after LC compare to traditional opioid analgesia, port-site infiltration and standard TAP.

Intraperitoneal (IP) instillation of local anaesthetics around the operative site is used as an analgesic technique on the assumption that conduction from visceral sites is obstructed and may lessen the intensity of referred pain to the shoulder (C3, C4) which results from irritation of diaphragmatic innervations, i.e., phrenic nerve (C3, C4, C5) and diaphragmatic stretching due to gaseous distension, in the postoperative period. Narchi I' et al., as early as in 1991 had reported that instillation of local anaesthetic (80 mL of bupivacaine 0.125%, epinephrine (1:200,000) under the right diaphragm reduced shoulder pain after minor gynaecologic laparoscopy.

Dexmedetomidine is a selective, short acting, agonist of the α2-adrenergic receptors. It has high affinity to α2-adrenergic receptors (more than eight-fold) and lower affinity to α1-receptors, compared with other α2-agonists agents, besides its great selectivity to α2A-adrenergic receptors, which is responsible for its analgesic effect. It has been used clinically as an adjunct to anesthesia and analgesia, and it is useful for painful surgical procedure and ICU sedation.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Seham M Moeen, MD; Phone Number: 02 01006386324; Email: seham.moeen@yahoo.com
• Study Contact Backup: Name: Dina H Ahmed, Msc; Phone Number: 02 01008207874; Email: Dr_dina_ahmed84@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut University
    • Contact: Seham M Moeen, M.D.; Phone Number: 02 01006386324; Email: seham.moeen@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing elective LC under general anesthesia, aged from 20 to 65 years old.

Exclusion Criteria:

• Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
• Altered conscious level
• Pregnancy
• Body mass index (BMI > 35)
• Patients who have difficulty understanding the study protocol 6- Patients who have any known contraindication to study medications 7- Patient refusal.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline.	Drug: USG-STAP with bupivacaine and dexmedetomidine; Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline
Placebo Comparator: Group II; Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery	Drug: IP bupivacaine and dexmedetomidine; Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intensity of postoperative pain	Assessed by the numerical rating pain scale (NRS)	24 hours after surgery

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2021
• Primary Completion (Anticipated): February 15, 2022
• Study Completion (Anticipated): February 15, 2022

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 7, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: SM 1, 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No