Transversus Abdominis Plane Block Versus Ilioinguinal-Iliohypogastric Nerve Block for Postoperative Analgesia Following Open Total Abdominal Hysterectomy

NCT05656872 | Completed

• 1 other identifier: MS-617-2021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators hypothesised that ultrasound-guided transversus abdominis plane (TAP) block would prolong the time to first rescue nalbuphine within 24 hours compared with ultrasound-guided ilioinguinal-iliohypogastric (IIH) nerve block, by virtue of its broader dermatomal coverage (T10-L1 versus T12-L1) of the Pfannenstiel incision. This hypothesis direction was established before unblinding and data analysis.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Time to first rescue nalbuphine within 24 hours

  Time from end of surgery to first administration of rescue nalbuphine (0.15 mg.kg-¹ intravenously, given when numerical rating scale pain score ≥ 4 at rest after 30 minutes).

  From end of surgery to first rescue dose within 24 hours postoperatively

Secondary Outcomes (4)

• Total nalbuphine consumption within 24 hours

  Immediate 24 hours post-operative

• Numerical Rating Scale (NRS)

  5 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, and 24 hours after arrival in the post-anaesthesia care unit

• Intraoperative and postoperative haemodynamics (heart rate and mean arterial pressure)

  Baseline, every 10 minutes intraoperatively, immediately after extubation, 5 minutes after extubation, every 10 minutes in PACU for 30 minutes, then at 2, 4, 8, 12, 18, and 24 hours postoperatively

• Incidence of postoperative nausea and vomiting

  Immediate 24 hours post-operative

Study Arms (2)

TAP Block

ACTIVE COMPARATOR

Transversus abdominus plane (TAP) block will be used as postoperative analgesia

Procedure: Transverse Abdominis Plane Block

IIIH Block

ACTIVE COMPARATOR

Ilioinguinal-iliohypogastric (IIIH) block will be used as postoperative analgesia

Procedure: Ilioinguinal-iliohypogastric block

Interventions

Transverse Abdominis Plane Block PROCEDURE

Group T, will be performed in a supine position after skin sterilization, a linear high-frequency transducer GE Healthcare 12L-RS ultrasound will be placed in the transverse plane to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest. The abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) will be visualized. A blunt tip,20-gauge, short bevel needle(B Braun Contiplex 22G echogenic needle, 80-100 mm) will be inserted in-plane and advanced anterior to posterior under continuous visualization until the tip reaches between the internal oblique and the transversus abdominis muscle. After negative aspiration, 20 mL of bupivacaine 0.25%, lidocaine 1% will be injected. Separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in-between will be observed. The procedure will be repeated following the same steps on the other side.

TAP Block

Ilioinguinal-iliohypogastric block PROCEDURE

Group I, will receive an Ultrasound-guided IIIH block that will be performed in a supine position after skin sterilization, a linear high-frequency transducer GE Healthcare 12L-RS ultrasound will be placed on the line between the anterior superior iliac spine and the umbilicus, where 3 layers of muscles (extra-abdominal oblique, intra-abdominal oblique, and transverse abdominis) will be visible on the inner side of the anterior superior iliac spine.A blunt tip,20-gauge, short bevel needle( Braun Contiplex 22G echogenic needle, 80-100 mm) will be inserted in-plane and advanced anterior to posterior under continuous visualization until the tip reaches between the internal oblique and the transversus abdominis muscle next to the iliohypogastric/ilioinguinal nerve. After negative aspiration, 20 mL of bupivacaine 0.25%, lidocaine 1% will be injected. The procedure will be repeated following the same steps on the other side.

IIIH Block

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be adult patients (35-65 years)
• ASA I-III
• Scheduled for elective open TAH

You may not qualify if:

• Patient refusal
• BMI \> 40 kg·m-²
• Pregnancy
• Chronic pain requiring daily analgesics
• Any known allergy to local anesthetic, nalbuphine, paracetamol, or diclofenac
• Patients with neurological, psychological disorders or those lacking cooperation
• Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
• Patients with bleeding disorders defined as (INR \>2) and/ or (platelet count \<100,000/µL)
• Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Location

Mohamed Ollaek

Cairo, Egypt

Location

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

• Mohamed A Ollaek, MD

  Department of Anesthesia, Surgical ICU and Pain Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, operating surgeons, ward nursing staff, and outcome assessors were all blinded to group allocation, achieved through sealed-envelope concealment and separation of the block performer from all postoperative care and assessment. This represents an enhancement of blinding beyond the originally registered single-blinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 19, 2022
• Study Start: November 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: April 30, 2023
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)