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

NCT ID: NCT06695468

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-01-01

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.

Detailed Description

Postoperative pain may cause tachycardia, hypertension, increased cardiac work, nausea, vomiting and ileus. Also, if it is inadequately managed it may lead to hazardous cardiovascular effects, pulmonary dysfunction, immune system, neuro-endocrine and metabolic effects, gastrointestinal- urinary- and cognitive dysfunction and also have psychological, economic and social adverse effects. Therefore, effective pain management is a priority of care and a patient's right.

The American Society of Anesthesiologists recommends use of multimodal pain regimens to minimize opioid use and improve pain control . Opioids are still the go-to medication for treating visceral pain, but they are ineffective against somatic discomfort. An effective Multimodal pain management protocol uses combinations of opioid prescriptions, nonopioid prescription, regional and local anesthesia, and nonpharmacological therapy . To mitigate the adverse consequences of opioid overconsumption, peripheral and regional anesthetic blocks were implemented. The Quadratus lumborum block is one of the perioperative pain management procedures that is administered to patients of all ages who are undergoing abdominal surgery . Nevertheless, there is persistent disagreement regarding the optimal method of administering the block due to the ambiguous mechanisms that are responsible for its effects.

We sought an alternative, such as the Rectus sheath block, to prevent postoperative somatic pain, due to the potential complications of the QLB technique, including retroperitoneal hemorrhage, abscess, and pleural injury . The block was not frequently applied, or insufficient blocks could not be achieved primarily with a single injection method prior to taking advantage of ultrasonography. This was due to the proximity of medicated zones and vital organs, as well as the coherent and thin muscle layers. Currently, this approach is being implemented with catheter placement in the rectus sheath, ultrasonography guidance, and a single injection .

At present, several adjuvants have been added to local anesthetics used in peripheral and regional blocks to decrease the dosage of local anesthetic and enhance its effectiveness . Dexmedetomidine is an adjuvant that acts as a selective alpha two adrenoreceptor stimulating agent. This medication induces drowsiness, analgesia, sympatholysis, and anxiolysis in a dose-dependent manner, without causing significant respiratory depression.

Conditions

Abdominal Cancer Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Quadratus lumborum block (QLB group)

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).

Group Type: EXPERIMENTAL

Levobupivacaine

Intervention Type: 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

Rectus sheath block (RSB group)

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).

Group Type: EXPERIMENTAL

Levobupivacaine + Dexmedetomidine

Intervention Type: 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).

Interventions

Levobupivacaine

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

Intervention Type: DRUG

Levobupivacaine + Dexmedetomidine

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients subjected to major lower abdominal cancer surgeries.

2. The enrolled age will be from 18 years to 70 years

3. ASA I-III and NYHA I-III.

Exclusion Criteria

1. ASA physical status >III and NYHA>III

2. Patient refusal

3. Body mass index >40 kg/m2

4. Preoperative opioid consumption

5. Infection at the incision site

6. A history of hematological disorders or coagulation abnormality

7. Previous abdominal surgeries, severe hepatic or renal impairment

8. Pregnant women

10- Hypersensitivity to any of used drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Kerollos Ibrahim Gayed Ibrahim

resident doctor at Anaesthesia, I.C.U and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kerollos Ibrahim Gayed Ibrahim, resident doctor

Role: CONTACT

Cerles.16266305@med.aun.edu.eg

+201282351859

References

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.

Reference Type: BACKGROUND

PMID: 22301064 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15448529 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29929169 (View on PubMed)

Other Identifiers

dexmedetomidine QLB

Identifier Type: -

Identifier Source: org_study_id