Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane (TAP) Block

NCT06943456 | Not Yet Recruiting

• 1 other identifier: Exp131
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to compare two types of pain management techniques in patients undergoing open appendectomy (surgical removal of the appendix through a traditional incision). One group of patients will receive a Transversus Abdominis Plane (TAP) block, a type of regional anesthesia given at the end of surgery to numb the abdominal area and reduce pain. The other group will undergo the same surgery without receiving the TAP block. The purpose of this study is to find out whether adding the TAP block helps in: Reducing postoperative pain Shortening the hospital stay Minimizing complications like nausea, vomiting, and delayed mobility Improving patient satisfaction after surgery Opioid medications are commonly used for pain control after surgery, but they come with side effects such as nausea, vomiting, dizziness, and risk of dependency. TAP block offers a promising alternative that may reduce or eliminate the need for opioids by targeting specific nerves in the abdominal wall. This will be a randomized controlled trial (considered the gold standard in medical research), meaning patients will be randomly assigned to one of the two groups to ensure fair comparison. The study will enroll 136 adult patients who are diagnosed with appendicitis and are scheduled for open appendectomy at Jinnah Hospital Lahore. By conducting this study, the researchers aim to provide strong scientific evidence on whether TAP block should be routinely used in appendectomy patients to enhance recovery and comfort. If proven effective, this could influence hospital protocols and improve post-surgery care both locally and internationally.

Conditions

Appendicitis; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Postoperative pain will be measured using the Visual Analog Scale (VAS) at 12, 16, and 24 hours post-surgery. The VAS is a scale where 0 represents no pain and 10 represents the worst possible pain. Patients will mark their pain intensity on a 10 cm line, and the score is measured by the distance (in centimeters) from the 'no pain' mark to the point marked by the patient. This scale provides a continuous variable to assess pain intensity, allowing a detailed understanding of pain levels over time. The VAS score will be used to compare the pain outcomes between the two groups (TAP block versus no TAP block).

  12, 16, and 24 hours post-surgery

Study Arms (2)

Open Appendectomy with Transversus Abdominis Plane (TAP) Block

EXPERIMENTAL

Patients in this group will undergo open appendectomy followed by the administration of a Transversus Abdominis Plane (TAP) block. The TAP block will be performed using a mixture of 10 ml of 1% lignocaine and 10 ml of 0.5% bupivacaine, injected between the transversus abdominis and internal oblique muscles under vision. This intervention is designed to provide localized post-operative analgesia and reduce the need for systemic opioid analgesics.

Procedure: Transversus Abdominis Plane (TAP) Block for Postoperative Pain Management

Open Appendectomy without Transversus Abdominis Plane (TAP) Block

ACTIVE COMPARATOR

Patients in this group will undergo open appendectomy using the standard surgical technique without the administration of a Transversus Abdominis Plane (TAP) block. Post-operative pain will be managed using standard opioid analgesia as required, without the benefit of the TAP block for localized pain relief.

Procedure: Standard Open Appendectomy with Postoperative Pain Management

Interventions

Transversus Abdominis Plane (TAP) Block for Postoperative Pain Management PROCEDURE

The intervention involves the administration of a Transversus Abdominis Plane (TAP) block performed at the end of an open appendectomy surgery. A mixture of 10 ml of 1% lignocaine and 10 ml of 0.5% bupivacaine is injected into the transversus abdominis plane, located between the transversus abdominis and internal oblique muscles, under direct vision. This procedure aims to provide localized pain relief by blocking the sensory nerves of the anterior abdominal wall, reducing the need for systemic opioid analgesics during post-operative recovery

Open Appendectomy with Transversus Abdominis Plane (TAP) Block

Standard Open Appendectomy with Postoperative Pain Management PROCEDURE

The intervention involves the standard open appendectomy surgical procedure without the addition of a Transversus Abdominis Plane (TAP) block. Postoperative pain management in this group is managed using standard opioid analgesics. No local anesthetic block is performed, and pain management is entirely reliant on systemic medications, including opioids, for post-operative recovery

Open Appendectomy without Transversus Abdominis Plane (TAP) Block

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 65 years.
• Both male and female patients.
• Patients fit for general anesthesia.
• Clinical findings of appendicitis.
• Lower right quadrant or periumbilical pain radiating to the right lower quadrant, with nausea and/or vomiting.
• Fever \>38°C.
• Tenderness with Alvarado score \>7.

You may not qualify if:

• Duration of symptoms \>5 days.
• Absence of clinical findings of appendicitis.
• Palpable mass on physical examination suspected for appendiceal abscess.
• History of cirrhosis or hematological disorders.
• Allergic to or contraindicated for general anesthesia.
• Pregnancy.
• Patients who do not consent to participate.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Appendicitis; Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Hafiz Rana Kamran Ijaz, MS General Surgery

CONTACT

0331-4745037; beekeeperrkrajput@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two parallel groups: Group A will receive a Transversus Abdominis Plane (TAP) block following open appendectomy. Group B will undergo the same surgical procedure without a TAP block. Each group will receive only one type of intervention, and both will be observed independently for outcomes such as postoperative pain, complications, and hospital stay.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04