Efficacy and Safety of Adding Dexmedetomidine to Levobupivacaine in Rectus Sheath Block Compared to Quadratus Lumborum Block in Patients Undergoing Lower Abdominal Cancer Surgery: a Randomized Clinical Trial

NCT06695468 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: dexmedetomidine QLB
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

Surgical trauma activates numerous receptors leading to severe postoperative pain. Seventy to seventy-five percent of the pain is somatic, originating from the anterior abdominal wall, and it often persists for 72 hours after open surgery. The objective of this study is to compare the efficacy and safety of adding dexmedetomidine to Levobupivacaine in rectus sheath block with quadrates lumborum block in patients undergoing lower abdominal cancer surgeries.

Conditions

Abdominal Cancer Surgery

Keywords

Quadratus Lumborum Block; dexmedetomidine; Levobupivacaine; Rectus sheath block

Outcome Measures

Primary Outcomes (1)

• pain intensity

  measured by VAS immediately postoperatively, then at 2-, 4-, 6-, 8-, 12-, 18-, 24-hours after surgery.

  24 hours

Study Arms (2)

Quadratus lumborum block (QLB group)

EXPERIMENTAL

patients will receive bilateral QLB with a 40-ml mixture of 20 ml of 0.5% levobupivacaine diluted with 20 ml of 0.9% N.S. (20 ml to be injected on each side).

Drug: Levobupivacaine

Rectus sheath block (RSB group)

EXPERIMENTAL

patients will receive bilateral RSB with a 60 ml mixture of 1.5 mic/kg dexmedetomidine added to 30 ml of 0.5% levobupivacaine diluted with 30 ml of 0.9% N.S. (30 ml to be administered on each side, divided into 15 ml for the upper segment and 15 ml for the lower segment).

Drug: Levobupivacaine + Dexmedetomidine

Interventions

Levobupivacaine DRUG

40-ml mixture of 20 ml of 0.5% levobupivacaine diluted with 20 ml of 0.9% N.S. (20 ml to be injected on each side

Quadratus lumborum block (QLB group)

Levobupivacaine + Dexmedetomidine DRUG

60 ml mixture of 1.5 mic/kg dexmedetomidine added to 30 ml of 0.5% levobupivacaine diluted with 30 ml of 0.9% N.S. (30 ml to be administered on each side, divided into 15 ml for the upper segment and 15 ml for the lower segment).

Rectus sheath block (RSB group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients subjected to major lower abdominal cancer surgeries.
• The enrolled age will be from 18 years to 70 years
• ASA I-III and NYHA I-III.

You may not qualify if:

• ASA physical status \>III and NYHA\>III
• Patient refusal
• Body mass index \>40 kg/m2
• Preoperative opioid consumption
• Infection at the incision site
• A history of hematological disorders or coagulation abnormality
• Previous abdominal surgeries, severe hepatic or renal impairment
• Pregnant women
• Hypersensitivity to any of used drugs

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Zheng Y, Cui S, Liu Y, Zhang J, Zhang W, Zhang J, Gu X, Ma Z. Dexmedetomidine prevents remifentanil-induced postoperative hyperalgesia and decreases spinal tyrosine phosphorylation of N-methyl-d-aspartate receptor 2B subunit. Brain Res Bull. 2012 Mar 10;87(4-5):427-31. doi: 10.1016/j.brainresbull.2012.01.009. Epub 2012 Jan 25.

  PMID: 22301064 BACKGROUND

• Moen V, Dahlgren N, Irestedt L. Severe neurological complications after central neuraxial blockades in Sweden 1990-1999. Anesthesiology. 2004 Oct;101(4):950-9. doi: 10.1097/00000542-200410000-00021.

  PMID: 15448529 BACKGROUND

• 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: 29929169 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Kerollos Ibrahim Gayed Ibrahim, resident doctor

CONTACT

+201282351859; [email protected]

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A computer-generated database of random numbers will be used to randomly assign patients into two groups in a 1:1 ratio. The randomization will be carried out using a numbered, opaque, and sealed envelope.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anaesthesia, I.C.U and pain management

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11