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Clinical Trials/NCT04553991
NCT04553991CompletedNot Applicable

Analgesic Effect of Ultrasound-Guided Bilateral Quadratus Lumborum Block (Lateral Approach) Versus Bilateral Transversus Abdominis Plane Block With General Anesthesia in Laparoscopic Abdominal Surgery (Randomized Controlled Clinical Trial)

Fayoum University Hospital1 site in 1 country50 target enrollmentStarted: July 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
The total morphine consumption at first 24 hours postoperatively

Study Overview

Brief Summary

The transversus abdominis plane (TAP) block is an already established technique and is considered now as an efficient part of the multimodal pain management approach for abdominal surgical procedures. The quadratus lumborum block (QLB) is a recently described regional block that was first described by Blanco et al , which has been reported to provide an effective analgesia for upper and lower abdominal surgeries. The aim of this study is to compare the analgesic efficacy of TAP block and QLB 1 after laparoscopic abdominal surgery regarding opioid consumption, duration of analgesia and visual analog score.

This prospective randomized controlled observer-blinded study compared between the analgesic efficacy between TAP block (n=25) versus QL block (n=25) in patients aged (18-60) years of American society of anesthesiologists physical status class I & II scheduled for elective laparoscopic abdominal surgical procedures. The primary outcome was the cumulative morphine consumption at first 24 hours postoperatively. Secondary outcomes included VAS scores, first analgesic requirements and any postoperative complications

Detailed Description

This prospective randomized, observer-blinded paralleled groups study was conducted following the tents of the Declaration of Helsinki. This study was approved by the local institutional ethics committee and local institutional review board of Fayoum university hospital and written informed consent was obtained from 50 adult patients scheduled for elective laparoscopic abdominal surgical procedures (inguinal hernia repair-missed IUCD extraction-appendectomy-ovarian vein ligation) between July 2019 and February 2020.

Patients were randomly allocated into two groups (QLB group n=25 and TAPB group n=25) using computer generated random numbers kept in separate opaque envelopes that were opened by the study investigator just before the block. The patient and the data collector were unaware of the group allocation till the end of the study.

Pre-operative assessment (History, examination and investigations) was done (according to the local protocol designed to evaluate the patients). Demographic characteristics: age, weight, height and BMI were recorded in preoperative assessment of patients. All patients received 150 mg Ranitidine oral tablet at night and on the morning just before the operation as a premedication. Before surgery, the participants received education about the VAS pain score (0-10) (where 0 = no pain and 10 = worst comprehensible pain) and the details of the nerve block procedures. After a 6 hrs fasting, the patients were taken to the operation theatre.

Upon arrival to the operating room standard monitors (Pulse oximeter, noninvasive blood pressure monitoring, capnography and electrocardiogram) were applied and continued all over the operation, an 18 gauge peripheral intravenous (IV) cannula was inserted, IV midazolam 0.03 mgkg-1, metoclopramide 10 mg, and ceftriaxone 1 gm were administered to all patients as premedication then pre-oxygenation with O2 100% for at least 3 min then induction of anesthesia was done with fentanyl 1μgkg-1, propofol 1.5-2 mgkg-1 and atracurium 0.5 mgkg-1. Anesthesia was maintained by volume controlled ventilation (VCV) tidal volume 6-8 mlkg-1 with oxygen and air (50:50) with target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 % volume concentration and atracurium 0.1 mgkg-1 every 20-30 minutes.

The study solution was prepared in two syringes each contained 20 ml of bupivacaine 0.25%. By the end of surgery and before recovery from general anesthesia, either blocks were done using a high-frequency ultrasound probe Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips healthcare, Andover MA01810, USA) and a 22-gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients scheduled for elective laparoscopic abdominal surgeries (inguinal hernia repair-missed IUCD extraction-appendectomy-ovarian vein ligation)
  • •Patient aged 18-60 years
  • •American Society of Anesthesiologists Physical Status I or II.

Exclusion Criteria

  • •Patient refusal
  • •Body mass index (BMI) > 40 kilogram/square meter
  • •Contraindication to regional anesthesia (coagulopathy, allergy to local anesthetic, sever thrombocytopenia or infection at puncture site)
  • •Chronic pain condition requiring the intake of opioids at home
  • •Any significant neurological, cardiovascular or respiratory disease.

Arms & Interventions

QL block group

Active Comparator

For the ultrasound-guided quadratus lumborum block group, the patient was placed in lateral position . QL was identified medial to the aponeurosis of transversus abdominis muscle. Then the needle was inserted from supero-anterior to postero-inferior and advanced using in plane technique till the needle tip reached the anterolateral border of the QL at its junction with transversalis fascia.An injection of 20 mL of 0.25% bupivacaine was applied bilaterally

Intervention: Ultrasound guided QL block (Procedure)

TAP block group

Active Comparator

For the ultrasound-guided TAP block,The probe was placed in the mid-axillary line above the level of the anterior superior iliac spine, then slided cranially till the three abdominal wall muscles identified (External oblique muscle (EAO), internal oblique muscle (IOM) and transverse abdominis muscle (TAM)). The needle was advanced using in-plane technique till it reached the transvers abdominis plane. An injection of 20 mL of 0.25% bupivacaine was applied bilaterally

Intervention: Ultrasound guided TAP block (Procedure)

Outcomes

Primary Outcomes

The total morphine consumption at first 24 hours postoperatively

Time Frame: 24 hours postoperatively

amount of morphine used in milligram after each block

Secondary Outcomes

  • frequency of patients required postoperative opioid.(First 24 hours postoperatively)
  • incidence of postoperative nausea and vomiting(First 24 hours postoperatively)
  • incidence of postoperative sedation at 30 min postoperatively(at 30 minutes postoperatively)
  • Postoperative pain, assessed using visual analog scale (VAS) score at 30 min postoperatively.(30 minutes postoperatively)
  • Postoperative pain, assessed using visual analog scale (VAS) score at 2 h postoperatively.(2 hours postoperatively)
  • Postoperative pain, assessed using visual analog scale (VAS) score at 4 h postoperatively.(4 hours postoperatively)
  • Postoperative pain, assessed using visual analog scale (VAS) score at 6 h postoperatively.(6 hours postoperatively)
  • Postoperative pain, assessed using visual analog scale (VAS) score at 12 h postoperatively.(12 hours postoperatively)
  • Postoperative pain, assessed using visual analog scale (VAS) score at 24 h postoperatively.(24 hours postoperatively)
  • Time to the first analgesic request(24 hours postoperatively)
  • incidence of postoperative sedation at 12 h postoperatively(at 12 hours postoperatively)
  • incidence of postoperative sedation at 24 h postoperatively(at 24 hours postoperatively)
  • incidence of visceral injury(in the first 24 hours postoperatively)
  • incidence of postoperative pruritus(First 24 hours postoperatively)
  • incidence of postoperative sedation at 2 h postoperatively(at 2 hours postoperatively)
  • incidence of postoperative sedation at 6 h postoperatively(at 6 hours postoperatively)
  • incidence of local anesthetic systemic toxicity(in the first 24 hours postoperatively)
  • incidence of vascular injury(in the first 24 hours postoperatively)
  • incidence of local hematoma(in the first 24 hours postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammed abdelaleem

The Analgesic Effect of Ultrasound-Guided Bilateral Quadratus Lumborum Block (lateral Approach) Versus Bilateral Transversus Abdominis Plane Block with General Anesthesia in Laparoscopic abdominal surgery (Randomized Controlled Clinical Trial)

Fayoum University Hospital

Study Sites (1)

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