NCT06950502

Brief Summary

Midline incisions provide easy, rapid and excellent exposure of the abdominal cavity and are particularly used for complex, diagnostic or emergency procedures. However, midline incisions transect the nerve fibers passing in the mediocaudal direction of the abdominal wall, which causes more postoperative pain than other incisions. Postoperative pain and delayed return of bowel function are thought to be the main factors that prevent early recovery and discharge. or surgical procedures where parietal pain is the main component of postoperative pain, TAPB can be used as a simple and effective analgesic technique with the added advantage of preserved motor and bladder function. Quadratus lumborum block can be used as an analgesic technique in all surgeries such as proctosigmoidectomy, hip surgery, above-knee amputation, abdominal hernia repair, breast reconstruction, colostomy closure, radical nephrectomy, lower extremity vascular surgery, total hip arthroplasty, laparotomy and colectomy. Our study aimed to compare the effects of bilateral oblique subcostal TAPB with bilateral QLB2 and QLB3 performed under ultrasound guidance in midline incision laparotomies on total opioid requirement in the first 24 hours postoperatively, early postoperative pain intensity, time to first rescue analgesic requirement, nausea, vomiting and pruritus. To evaluate this hypothesis, we compared TAPB and QLB in a prospective, randomized, single-center clinical study. The primary endpoint of our study was the comparison of total morphine consumption in the first 24 hours postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

April 20, 2025

Last Update Submit

April 30, 2025

Conditions

Keywords

Oblique subcostal transversus abdominis plane blockQuadratus lumborum blockPainRegional Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Our study aimed to compare the effects of bilateral oblique subcostal TAPB with bilateral QLB2 and QLB3 performed under ultrasound guidance in midline incision laparotomies on total opioid requirement in the first 24 hours postoperatively

    All patients were extubated after the block was performed. All patients were given 1 mg bolus 10 min lock time IV morphine (Morphine Hydrochloride, OSEL Drug) connected to the PCA device (BodyGuard 575i Pain Manager, TARMED). If the morphine given with the PCA device was not sufficient as an analgesic, patients were given 1 gr IV paracetamol infusion (the dose was adjusted so that the paracetamol dose did not exceed a maximum of 4 grams per day). If the VAS was still \>4 at 1 hour after paracetamol, the patient was administered 50 mg IV dexketoprofen (NSAID) (the dexketoprofen dose was adjusted to a maximum of 150 milligrams per day).he amount of opioids used and requested by the patients was recorded as the amount of PCA medication at the 15th minute, 2nd, 4th, 8th, 12th, 16th and 24th hours, as how much opioids they requested or used at the specified time intervals. For example, the amount of opioid used between the 15th minute and the 2nd hour was recorded at the 2nd hour.

    Within 24 hours after surgery

Study Arms (2)

Quadratus Lumborum Group (QLB)

ACTIVE COMPARATOR

Quadratus lumborum block; after the patient was lying in the lateral decubitus position and skin asepsis of the posterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the ultrasound probe was moved from the level of the iliac crest to the 4th lumbar vertebra and the quadratus lumborum muscle was visualized on the transverse process of the 4th lumbar vertebra at the point where the anterior abdominal wall muscles end. The needle was advanced in-plane between the quadratus lumborum muscle and the erector spinae-latissimus dorsi muscles (QLB2) located on the posterior-superior side of this muscle, and 0.15 ml/kg 0.25% bupivacaine was injected under the thoracolumbar fascia located between these two muscles. Then, the needle was advanced towards the quadratus lumborum and the psoas major (QLB3) muscle located on the anterior-inferior side, and 0.15 ml/kg 0.25% bupivacaine was injected between these two muscles.This procedure was applied to the patient bilaterally.

Procedure: Quadratus Lumborum Block (QLB)Drug: quadratus lumborum block using bupivacaine

Transversus Abdominis Plane Group (TAPB)

ACTIVE COMPARATOR

Transversus abdominis plane block was performed with the patient lying in the supine position via an oblique subcostal approach from the anterior abdominal wall. After skin asepsis of the anterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the linear ultrasound probe was placed parallel to the subcostal border at the level of the xiphoid bone and the subcutaneous fat tissue, rectus abdominis muscle and transversus abdominis muscle were visualized, respectively. A 10 cm 20G needle (BRAUN Stimuplex Ultra 360, GERMANY) was advanced towards the transversus abdominis muscle fascia with the in-plane technique and 0.3 ml/kg 0.25% bupivacaine was injected into this area.This procedure was performed bilaterally.

Procedure: transversus abdominis plane blockDrug: transversus abdominis plane block using bupivacaine

Interventions

Transversus abdominis plane block was performed with the patient lying in the supine position via an oblique subcostal approach from the anterior abdominal wall. After skin asepsis of the anterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the linear ultrasound probe was placed parallel to the subcostal border at the level of the xiphoid bone and the subcutaneous fat tissue, rectus abdominis muscle and transversus abdominis muscle were visualized, respectively. A 10 cm 20G needle (BRAUN Stimuplex Ultra 360, GERMANY) was advanced towards the transversus abdominis muscle fascia with the in-plane technique and 0.3 ml/kg 0.25% bupivacaine was injected into this area.This procedure was performed bilaterally.

Transversus Abdominis Plane Group (TAPB)

Quadratus lumborum block; after the patient was lying in the lateral decubitus position and skin asepsis of the posterior abdominal wall was provided with 10% polyvinylpyrrolidone-iodine, the ultrasound probe was moved from the level of the iliac crest to the 4th lumbar vertebra and the quadratus lumborum muscle was visualized on the transverse process of the 4th lumbar vertebra at the point where the anterior abdominal wall muscles end. The needle was advanced in-plane between the quadratus lumborum muscle and the erector spinae-latissimus dorsi muscles (QLB2) located on the posterior-superior side of this muscle, and 0.15 ml/kg 0.25% bupivacaine was injected under the thoracolumbar fascia located between these two muscles. Then, the needle was advanced towards the quadratus lumborum and the psoas major (QLB3) muscle located on the anterior-inferior side, and 0.15 ml/kg 0.25% bupivacaine was injected between these two muscles.This procedure was applied to the patient bilaterally.

Quadratus Lumborum Group (QLB)

The needle was advanced in-plane between the quadratus lumborum muscle and the erector spinae-latissimus dorsi muscles (QLB2) located on the posterior-superior side of this muscle, and 0.15 ml/kg 0.25% bupivacaine was injected under the thoracolumbar fascia located between these two muscles. Then, the needle was advanced towards the quadratus lumborum and the psoas major (QLB3) muscle located on the anterior-inferior side, and 0.15 ml/kg 0.25% bupivacaine was injected between these two muscles.This procedure was applied to the patient bilaterally.

Quadratus Lumborum Group (QLB)

A 10 cm 20G needle (BRAUN Stimuplex Ultra 360, GERMANY) was advanced towards the transversus abdominis muscle fascia with the in-plane technique and 0.3 ml/kg 0.25% bupivacaine was injected into this area.This procedure was performed bilaterally.

Transversus Abdominis Plane Group (TAPB)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laparotomy with midline incision
  • General anesthesia will be applied
  • years old
  • ASA 1-3
  • BMI of 18-30 kg/m2
  • Literate
  • Without cognitive impairment
  • Patients who approved the informed consent form

You may not qualify if:

  • Under 18 years old
  • Over 70 years old
  • ASA 4 and above
  • Cognitive impairment
  • İlliteracy
  • Vision and hearing problem
  • Infection at the injection site
  • Coagulopathy
  • Peripheral neuropathy
  • Local anesthetic allergy
  • Patients who do not want to be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.

    PMID: 30688787BACKGROUND
  • Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.

    PMID: 20830871BACKGROUND
  • Mrunalini P, Raju NV, Nath VN, Saheb SM. Efficacy of transversus abdominis plane block in patients undergoing emergency laparotomies. Anesth Essays Res. 2014 Sep-Dec;8(3):377-82. doi: 10.4103/0259-1162.143153.

    PMID: 25886339BACKGROUND
  • Liang SS, Ying AJ, Affan ET, Kakala BF, Strippoli GF, Bullingham A, Currow H, Dunn DW, Yeh ZY. Continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults. Cochrane Database Syst Rev. 2019 Oct 19;10(10):CD012310. doi: 10.1002/14651858.CD012310.pub2.

    PMID: 31627242BACKGROUND

Related Links

MeSH Terms

Conditions

Bites and StingsPain

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 30, 2025

Study Start

March 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 5, 2023

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

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