NCT04553991

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

September 5, 2020

Last Update Submit

September 12, 2020

Conditions

Abdominal Pain

Keywords

laparoscopyQL blockTAP block

Outcome Measures

Primary Outcomes (1)

  • The total morphine consumption at first 24 hours postoperatively

    amount of morphine used in milligram after each block

    24 hours postoperatively

Secondary Outcomes (19)

  • 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

  • +14 more secondary outcomes

Other Outcomes (4)

  • Patient's age

    15 minutes before operation

  • Patient's weight

    15 minutes before operation

  • Patient's height

    15 minutes before operation

  • +1 more other outcomes

Study Arms (2)

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

Procedure: Ultrasound guided QL block

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

Procedure: Ultrasound guided TAP block

Interventions

Ultrasound guided QL blockPROCEDURE

20 mL of 0.25% bupivacaine was applied bilaterally at the anterolateral border of the QL at its junction with transversalis fascia

QL block group
Ultrasound guided TAP blockPROCEDURE

20 mL of 0.25% bupivacaine was applied bilaterally in the TAP

TAP block group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • Sepsis
  • Chronic pain condition requiring the intake of opioids at home
  • Any significant neurological, cardiovascular or respiratory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Fayoum Governorate, 63514, Egypt

Location

Related Publications (3)

  • Kumar GD, Gnanasekar N, Kurhekar P, Prasad TK. A Comparative Study of Transversus Abdominis Plane Block versus Quadratus Lumborum Block for Postoperative Analgesia following Lower Abdominal Surgeries: A Prospective Double-blinded Study. Anesth Essays Res. 2018 Oct-Dec;12(4):919-923. doi: 10.4103/aer.AER_158_18.

    PMID: 30662131BACKGROUND

  • Okmen K, Metin Okmen B, Topal S. Ultrasound-guided posterior quadratus lumborum block for postoperative pain after laparoscopic cholecystectomy: A randomized controlled double blind study. J Clin Anesth. 2018 Sep;49:112-117. doi: 10.1016/j.jclinane.2018.06.027. Epub 2018 Jun 18.

    PMID: 29929169BACKGROUND

  • Fargaly OS, Boules ML, Hamed MA, Aleem Abbas MA, Shawky MA. Lateral Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Laparoscopic Surgery: A Randomized Controlled Study. Anesthesiol Res Pract. 2022 Mar 28;2022:9201795. doi: 10.1155/2022/9201795. eCollection 2022.

    PMID: 35386840DERIVED

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Maged L boules, MD

    Faculty of medicine, Fayoum university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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)

Study Record Dates

First Submitted

September 5, 2020

First Posted

September 18, 2020

Study Start

July 1, 2019

Primary Completion

February 1, 2020

Study Completion

May 1, 2020

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)