Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy

NCT06653803 | Recruiting

• 1 other identifier: DTH: 24001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. Both Rhomboid intercostal block (RIB) and Retrolaminar block (RLB) are recent techniques used for pain control after such procedures Objectives: To compare the effectiveness of RIB and RLB in providing postoperative analgesia after thoracoscopic sympathectomy in adult patients and their impact on the patient's outcomes. Patients and Methods: This prospective, randomized (1:1), double-blind clinical trial; will be carried out on 60 patients scheduled for elective thoracoscopic sympathectomy under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group A; general anesthesia with intraoperative ipsilateral ultrasound-guided RIB, whereas in group B; general anesthesia with intraoperative ipsilateral ultrasound-guided RLB.

Conditions

Post Operative Pain

Keywords

Rhomboid Intercostal Block; Retrolaminar Block; Regional Analgesia

Outcome Measures

Primary Outcomes (1)

• Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)

  The time interval between the block performance and the first request of postoperative analgesia

  24 hours after the end of surgery

Secondary Outcomes (2)

• Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)

  24 hours after the end of surgery

• Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)

  24 hours after the end of surgery

Study Arms (2)

Group A (n=30)

ACTIVE COMPARATOR

Rhomboid Intercostal Block

Procedure: Rhomboid Intercostal Block (RIB)

Group B (n=30)

ACTIVE COMPARATOR

Retrolaminar Block

Procedure: Retrolaminar Block (RLB)

Interventions

Rhomboid Intercostal Block (RIB) PROCEDURE

Intraoperative Ipsilateral Ultrasound-guided RIB

Group A (n=30)

Retrolaminar Block (RLB) PROCEDURE

Intraoperative Ipsilateral Ultrasound-guided RLB

Group B (n=30)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status ≤ II
• Age from 18 to 60 years
• Body Mass Index (BMI) \< 35 kg/m²

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical status \> II
• Age \< 18 years or \> 60 years
• Body Mass Index (BMI) ≥ 35
• Local infection at the puncture site
• Altered mental status
• Pregnant women
• Allergy to study drugs
• Chronic pain
• Coagulation abnormalities or on anticoagulants
• Severe hepatic or kidney disease

Sponsors & Collaborators

• Damanhour Teaching Hospital: lead

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

RECRUITING

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

• Ahmed M Shaat, MD

  Damanhour Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Shaat, MD

CONTACT

00201223482709; ahmedshaat99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 30, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-07

Locations

EG (1)