NCT06663345

Brief Summary

Laparoscopic cholecystectomy is associated with less pain than open surgery and a shorter recovery time. While the type of pain experienced after laparoscopy differs from that experienced after laparotomy, it is predominantly parietal pain (originating from the abdominal wall). However, patients also report visceral pain due to pneumoperitoneum. Various analgesic procedures, including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and regional anesthesia techniques, are employed as part of multimodal analgesia for postoperative pain. Regional anesthesia techniques for abdominal surgery include thoracic epidural analgesia, paravertebral block, and transversus abdominis plane (TAP) block. TAP block, one of the truncal blocks, has been utilized in numerous studies in the literature for the management of postoperative pain following abdominal surgery. TAPB is a nerve block technique that blocks sensory nerves by injecting local anesthetic into the plane between the transverse abdominis and internal oblique muscles. Although TAPB can effectively relieve somatic pain in patients undergoing minimally invasive laparoscopic surgery, it may not be suitable for visceral analgesia. Another truncal block that has gained recent attention is the Quadratus Lumborum Block (QLB). QLB is another nerve block technique that blocks sensory nerves by injecting local anesthetic into the interfascial plane between the quadratus lumborum and psoas muscles. QLB offers several advantages, including the ability to provide both somatic and visceral analgesia. This comprehensive approach can result in more effective postoperative analgesia during laparoscopic surgical procedures. Additionally, the use of TAPB or QLB may reduce opioid consumption, potentially improving analgesia in laparoscopic surgeries. The quadratus lumborum muscle can be blocked in four different ways: lateral, posterior, anterior, and intramuscular. In our study, the lateral quadratus lumborum block was the preferred approach. Opioids are the most commonly used narcotic analgesics for postoperative pain. Patients often require opioids for pain relief in the perioperative period, especially in abdominal surgery. However, the use of opioids can lead to a variety of side effects, including excessive sedation, postoperative nausea and vomiting, urinary retention, constipation, hyperalgesia, respiratory depression and immunosuppression. Opioids may have various effects on immune function, including modulation of cytokines, interaction with immune cells, affecting the neuroendocrine system and vascular permeability. These effects may contribute to postoperative complications such as infections and delayed wound healing due to increased inflammatory response. They may also prolong hospitalization. In order to reduce postoperative opioid consumption and opioid-related side effects, ultrasound-guided trunk block techniques are being developed in abdominal surgeries. Currently, ultrasound-guided multimodal analgesia techniques are widely used. Transversus abdominis plane block (TAPB) and quadratus lumborum block (QLB) are effective analgesic methods employed in conjunction with multimodal analgesia techniques during anesthesia. The objective of this study was to compare the effects of TAPB (transversus abdominis plane block) and QLB-1 (lateral quadratus lumborum block), which are frequently used in our clinic, on postoperative pain scores and the need for additional analgesics. Secondary objectives included postoperative opioid consumption, nausea and vomiting, hospital stay, and patient and surgeon satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2025

Typical duration for not_applicable postoperative-pain

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

First Submitted

Initial submission to the registry

July 1, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

July 1, 2024

Last Update Submit

March 20, 2026

Conditions

Keywords

TAP (transversus abdominis Plane) blockQLB-1 (Lateral Quadratum Lumborum ) blockNonopioid analgesiapostoperative painlaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (2)

  • A comparison of the effects of TAP (Transversus Abdominis Plane) block and QLB-1 (Lateral Quadratum Lumbarum) block and opioid consumption in laparoscopic cholecystectomy.

    Rate of opioid analgesic use mg/kg/day

    02.11.2024 - 02.05.2025 ( 6 months)

  • A comparison of the effects of TAP (Transversus Abdominis Plane) block and QLB-1 (Lateral Quadratum Lumbarum) block on postoperative pain in laparoscopic cholecystectomy.

    Pain Measures VAS (Visual Analog Scale) Minimum: 0- Maximum: 10

    02.11.2024 - 02.05.2025 ( 6 months)

Study Arms (2)

TAP (Transversus Abdominis Plan) Block

ACTIVE COMPARATOR

A bilateral TAP or QLB-1 block will be performed. This block is a standard procedure in our hospital for the management of postoperative pain.

Procedure: Transversus Abdominis Plan Block (TAPB), Lateral Quadratum Lumborum (QLB-1) Block

QLB-1 (Lateral Quadratum Lumborum ) Block

EXPERIMENTAL

Investigation of the efficacy of QLB-1 block compared to TAP block.

Procedure: Transversus Abdominis Plan Block (TAPB), Lateral Quadratum Lumborum (QLB-1) Block

Interventions

Following the acquisition of informed consent prior to surgery, 2 mg of intravenous midazolam will be administered to patients who volunteer. These patients will be monitored in the preoperative preparation room. Bilateral TAP or QLB-1 block will be performed, and this block is routinely applied for postoperative pain in our hospital.

QLB-1 (Lateral Quadratum Lumborum ) BlockTAP (Transversus Abdominis Plan) Block

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Consenting patients,
  • He's having a laparoscopic cholecystectomy,
  • ASA-I-II,
  • Between the ages of 18 and 64,
  • No history of anticoagulant or antiaggregant drug use,
  • Regional anesthesia is not contraindicated and the anesthesiologist is deemed appropriate for regional anesthesia,
  • Under general anesthesia and undergoing laparoscopic surgery,
  • Oriented and cooperative patients,

You may not qualify if:

  • \- Patients without consent
  • Regional anesthesia is contraindicated,
  • He's having open abdominal surgery,
  • Not in the appropriate age range,
  • Chronic diseases such as uncontrolled DM and HT,
  • Drug allergy,
  • Taking anticoagulants or antiaggregants,
  • History of chronic analgesic use,
  • Presence of active infection in the area to be blocked,
  • Will not be able to comply with postoperative pain /VAS follow-up,
  • Patients with ASA-IV-V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam ve Sakura Şehir Hastanesi

Istanbul, Başakşehir, 34480, Turkey (Türkiye)

Location

Related Publications (4)

  • Gao T, Wang Y, Zheng Y, Yu Y, Li Q, Zhang L. Quadratus lumborum block vs. transversus abdominis plane block for postoperative pain control in patients with nephrectomy: A systematic review and network meta-analysis. J Clin Anesth. 2024 Aug;95:111453. doi: 10.1016/j.jclinane.2024.111453. Epub 2024 Mar 25.

    PMID: 38531283BACKGROUND
  • Marcolin P, Amaral S, Motter SB, Brandao GR, de Oliveira Trindade B, Messer N, Poli de Figueiredo SM. Quadratus lumborum block versus transversus abdominis plane block for inguinal hernia repair: A systematic review and meta-analysis with trial sequential analysis. World J Surg. 2024 Mar;48(3):610-621. doi: 10.1002/wjs.12064. Epub 2024 Jan 24.

    PMID: 38265244BACKGROUND
  • Dai J, Lin S, Cui X, Xu Z, Zheng R, Wu D. The effects of ultrasound-guided QLB and TAPB combined with opioid-free anesthesia (OFA) on clinical efficacy of the patients undergoing abdominal surgery. Heliyon. 2023 Oct 11;9(10):e20878. doi: 10.1016/j.heliyon.2023.e20878. eCollection 2023 Oct.

    PMID: 37867884BACKGROUND
  • Sertcakacilar G, Yildiz GO. Analgesic efficacy of ultrasound-guided transversus abdominis plane block and lateral approach quadratus lumborum block after laparoscopic appendectomy: A randomized controlled trial. Ann Med Surg (Lond). 2022 Jun 14;79:104002. doi: 10.1016/j.amsu.2022.104002. eCollection 2022 Jul.

    PMID: 35860161BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeBites and Stings

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropaneDental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Emine OZCAN

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were unaware of group allocation. Postoperative pain assessment, VAS recordings, PCA usage, and adverse event monitoring were performed by a blinded outcome assessor. Due to the nature of the intervention, the anesthesiologist performing the block procedure was not blinded and was not involved in postoperative data collection or analysis.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-arm, randomized, parallel assignment trial comparing bilateral transversus abdominis plane (TAP) block versus bilateral lateral quadratus lumborum (QLB-1) block in patients undergoing elective laparoscopic cholecystectomy.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2024

First Posted

October 29, 2024

Study Start

January 2, 2025

Primary Completion

February 10, 2026

Study Completion

February 28, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations