Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia

NCT03323684 | Completed DMC

• 1 other identifier: MD/17.09.09
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

Brief Summary

In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain) due to trocar insertion sites, visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g., postlaparoscopic cholecystectomy syndrome). Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care. Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy. However, the efficacy of the TAP block is reportedly only reliable in providing analgesia below the umbilicus. The ultrasound-guided subcostal transversus abdominis (STA) block is a recently described variation on the TAP block which produces reliable supraumbilical analgesia. Deposition of local anesthetic in this plane has shown to block dermatomes T6 to T10 with an occasional spread to T12. This variant will be discussed in our study. Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic cholecystectomy has not been investigated before and it is the variant that will be discussed in our study.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Cumulative postoperative fentanyl consumption (total dose given in micrograms)

  For 24 hours after surgery

Secondary Outcomes (8)

• Cumulative intraoperative fentanyl consumption (total dose given in micrograms)

  For 4 hours after start of anaesthesia

• Heart rate

  For 4 hours after start of anaesthesia

• Mean arterial blood pressure (mmHg)

  For 4 hours after start of anaesthesia

• Dermatomal distribution of the extent of the blockade will be assessed by pinprick method

  the first one hour after surgery

• Postoperative pain severity will be assessed using VAS

  For 24 hours after surgery

Study Arms (3)

Quadratus lumborum block Group (QL)

EXPERIMENTAL

Quadratus lumborum block will be performed

Other: Quadratus lumborum block Group (QL); Drug: Paracetamol infusion; Drug: Ketorolac analgesia; Drug: fentanyl

Transversus abdominis plane Group (TAP)

EXPERIMENTAL

Subcostal transversus abdominis plane will be performed

Other: Transversus abdominis plane Group (TAP); Drug: Paracetamol infusion; Drug: Ketorolac analgesia; Drug: fentanyl

Control group (C)

EXPERIMENTAL

Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac

Other: Control group (C); Drug: Paracetamol infusion; Drug: Ketorolac analgesia; Drug: fentanyl

Interventions

Quadratus lumborum block Group (QL) OTHER

20 mL of 0.375% isobaric bupivacaine for each side deposited at the posterior aspect of the quadratus lumborum muscle (QLB type 2) using ultrasound after induction of general anesthesia and 15 minutes before start of surgery

Quadratus lumborum block Group (QL)

Transversus abdominis plane Group (TAP) OTHER

20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery

Transversus abdominis plane Group (TAP)

Control group (C) OTHER

No intervention will be done

Control group (C)

Paracetamol infusion DRUG

Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.

Control group (C); Quadratus lumborum block Group (QL); Transversus abdominis plane Group (TAP)

Ketorolac analgesia DRUG

In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.

Control group (C); Quadratus lumborum block Group (QL); Transversus abdominis plane Group (TAP)

fentanyl DRUG

With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.

Control group (C); Quadratus lumborum block Group (QL); Transversus abdominis plane Group (TAP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Physical Status I or II

You may not qualify if:

• Patient refusal.
• Hematological diseases
• bleeding disorders.
• Coagulation abnormality.
• Psychiatric diseases.
• Local skin infection
• sepsis at site of the block.
• Known intolerance to the study drugs.
• Body Mass Index \> 40 Kg/m2.
• Emergency laparoscopic cholecystectomy
• if laparoscopic procedure converted to open.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Mansoura University, Faculty of Medicine

Al Mansurah, DK, 050, Egypt

Location

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Control Groups; Fentanyl

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed Y Makharita, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 27, 2017
• Study Start: October 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 15, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

EG (2)