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

Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Other: Quadratus lumborum block Group (QL); Drug: Paracetamol infusion; Drug: Ketorolac analgesia; Drug: fentanyl; Other: Transversus abdominis plane Group (TAP); Other: Control group (C)

Detailed Description

The aim of this study is to compare the analgesic efficacy of ultrasound guided posterior quadratus lumborum block and subcostal transversus abdominis plane block in laparoscopic cholecystectomy. The primary outcome will be assessment of postoperative opioid analgesic requirements. The secondary outcomes will include assessing intraoperative analgesic requirements, stress of trocar insertion and insufflation, postoperative visual analogue scale (VAS), length of stay at post-anesthesia care unit (PACU), time of first request to analgesia, incidence of nausea, and vomiting.

The study will hypothesize that quadratus lumborum block will be more superior than or equal to transversus abdominis block because it could cover all the dermatome segments from caudally L1 to cranially till T6 segments as the drug is expected to travel from the QL to the higher paravertebral spaces.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura University
    • Mansourah, DK, Egypt, 050
      • mansoura university, faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Physical Status I or II

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadratus lumborum block Group (QL); Quadratus lumborum block will be performed	Other: Quadratus lumborum block Group (QL); 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; Drug: Paracetamol infusion; Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.; Drug: Ketorolac analgesia; In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.; Drug: fentanyl; 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.
Experimental: Transversus abdominis plane Group (TAP); Subcostal transversus abdominis plane will be performed	Drug: Paracetamol infusion; Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.; Drug: Ketorolac analgesia; In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.; Drug: fentanyl; 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.; Other: Transversus abdominis plane Group (TAP); 20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery
Experimental: Control group (C); Postoperative analgesia will be accomplished with conjunction of paracetamol and ketorolac	Drug: Paracetamol infusion; Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.; Drug: Ketorolac analgesia; In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.; Drug: fentanyl; 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.; Other: Control group (C); No intervention will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative postoperative fentanyl consumption (total dose given in micrograms)	For 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative intraoperative fentanyl consumption (total dose given in micrograms)	Cumulative use of fentanyl during intra-operative period	For 4 hours after start of anaesthesia
Heart rate	Changes in intra-operative heart rate values	For 4 hours after start of anaesthesia
Mean arterial blood pressure (mmHg)	Changes in intra-operative mean arterial blood pressure values	For 4 hours after start of anaesthesia
Dermatomal distribution of the extent of the blockade will be assessed by pinprick method	Assessment of dermatomal distribution of the block for evaluating the success or failure of the block	the first one hour after surgery
Postoperative pain severity will be assessed using VAS	The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain	For 24 hours after surgery
Time for the first request to rescue analgesia (in minutes)	Time for first request to rescue analgesia	For 24 hours after surgery
length of stay at PACU (in minutes)		For 24 hours after surgery
Incidence of postoperative nausea and vomiting		For 24 hours after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mohamed Y Makharita, MD, Professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Ketorolac; Acetaminophen
• Other Study ID Numbers: MD/17.09.09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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