Quadratus Lumborum Block for Total Abdominal Hysterectomy

NCT05765318 | Completed

• 1 other identifier: 150880200222
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Procedure specific postoperative pain management (PROSPECT) guidelines for abdominal hysterectomy published in 2006 recommended laparoscopic or vaginal hysterectomy as a preferred surgical technique. Multimodal postoperative pain management plane includes cyclooxygenase-2 (COX-2) selective inhibitors, and/or conventional non-steroidal antiinflammatory drugs (NSAID) in combination with strong opioids for high-intensity pain or with weak opioids for moderate- or low-intensity pain. Paracetamol also was recommended in combination with COX-2 inhibitors or conventional NSAIDs. Epidural analgesia was recommended for high-risk patients. PROSPECT guidelines updated in 2018 discuss only perioperative approach for laparoscopic hysterectomy. However, hysterectomy technique has been switched from total abdominal to laparoscopic approach. In low resources settings, laparoscopic technique is nor well developed neither available to many patients. Furthermore, the majority of patients undergo total abdominal hysterectomy (TAH), that is very painful procedure. Quadratus lumborum block (QLB) is a regional analgesic technique described by Blanco in 2007. Society for Obstetric Anesthesiology and Perinatology (SOAP) and European Society for Regional Anaesthesia and Pain Therapy (ESRA) recommended QLB for post-Cesarean pain management in cases where intrathecal morphine could not be used or for breakthrough pain. Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. The effects of QLB for laparoscopic hysterectomy is controversial. We would like to see if QLB can provide analgesic benefits in multimodal pain management after TAH in our clinical settings.

Conditions

Postoperative Pain

Keywords

Quadratus lumborum block; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine consumption (mg) during the first 12 postoperative hours

  Total dose of IV morphine that participants received during the first 12 hours after surgery

  12 hours after the end of surgery

Secondary Outcomes (4)

• Pain at rest

  2, 6, 12, and 24 hours after surgery

• Pain at mobilization

  2, 6, 12, and 24 hours after surgery

• Cumulated morphine consumption (mg) at 24 hours postoperatively

  24 hours after the end of surgery

• Time to first morphine demand

  24 hours after surgery

Other Outcomes (1)

• Postoperative nausea and vomiting (PONV)

  24 hours after surgery

Study Arms (2)

QLB group

EXPERIMENTAL

At the end of surgery, before emergence of anesthesia, participants will receive bilateral QLB and intravenous (IV) ketoprofen 100 mg. Ketoprofen 100 mg IV will be repeated every 12 hours. For breakthrough pain patients will receive an IV bolus of morphine 5 mg. IV bolus can be repeated after 20 min. The maximum is 8 boluses for 4 hours.

Procedure: QLB

Control group

NO INTERVENTION

At the end of surgery, before emergence of anesthesia, participants will receive IV ketoprofen 100 mg. Ketoprofen 100 mg IV will be repeated every 12 hours. For breakthrough pain patients will receive an IV bolus of morphine 5 mg. IV bolus can be repeated after 20 min. The maximum is 8 boluses for 4 hours.

Interventions

QLB PROCEDURE

QLB is ultrasound-guided injection of 30 ml bupivacaine 0.25% into quadratus lumborum plane posterior to the end of internal oblique muscle.

QLB group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Participants undergo total abdominal hysterectomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• endometrial carcinoma or uterine fibroids
• American society of anesthesiologists (ASA) physical status 1-3,
• Participant's body weight \> 50 kg,
• Written informed consent signed.

You may not qualify if:

• Patient's refusal
• Allergies to any study medication
• Local skin infection on the site of QLB injection
• \. Body mass index \> 40 kg/m2 4. Inability to comprehend or participate in scoring scales 4. Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane 5. Quadratus lumborum muscle plane not seen in ultrasound examination 6. Patients on regular use of opioids 7. Psychiatric disorders

Sponsors & Collaborators

• Clinical Center Niš: lead

Study Sites (1)

CCNis

Niš, 18000, Serbia

Location

Related Publications (7)

• Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3.

  PMID: 30914471 BACKGROUND

• Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28.

  PMID: 33370462 BACKGROUND

• Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.

  PMID: 33177330 BACKGROUND

• Akerman M, Pejcic N, Velickovic I. A Review of the Quadratus Lumborum Block and ERAS. Front Med (Lausanne). 2018 Feb 26;5:44. doi: 10.3389/fmed.2018.00044. eCollection 2018.

  PMID: 29536008 BACKGROUND

• Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

  PMID: 26225500 RESULT

• Hansen C, Dam M, Nielsen MV, Tanggaard KB, Poulsen TD, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2021 Jan;46(1):25-30. doi: 10.1136/rapm-2020-101931. Epub 2020 Oct 20.

  PMID: 33082286 RESULT

• Pejcic N, Kutlesic M, Velickovic I, Milic V, Kovacevic S, Jankovic RJ, Mitic D, Mitic R, Zornic N. Quadratus lumborum block for total abdominal hysterectomy: a double-blind, randomized, controlled trial. Turk J Med Sci. 2025 Feb 7;55(2):349-359. doi: 10.55730/1300-0144.5978. eCollection 2025.

  PMID: 40342315 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nada Pejcic, M.D.

  Leskovac General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Anaesthesiologoist, Principal investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: February 27, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 9, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact nada.pejcic@gmail.com

Locations

SE (1)