Clinical trial NCT06943456: Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane (TAP) Block
Official title: Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane Block
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Appendicitis
Postoperative Pain
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Open appendectomy is one of the most frequently performed emergency surgeries worldwide for the treatment of acute appendicitis. Postoperative pain following this surgery can delay recovery, prolong hospital stay, and increase the risk of complications such as respiratory distress and venous thromboembolism due to reduced mobility.

Traditionally, postoperative pain is managed using systemic analgesics, particularly opioids. However, opioids are associated with significant side effects such as nausea, vomiting, respiratory depression, gastrointestinal disturbances, dizziness, urinary retention, and risk of dependence. This has prompted the search for safer and more effective alternatives, especially in resource-limited settings.

The Transversus Abdominis Plane (TAP) block is a regional anesthesia technique that involves the injection of local anesthetics into the fascial plane between the internal oblique and transversus abdominis muscles. This approach targets the sensory nerves supplying the anterior abdominal wall (T6-L1), providing effective somatic pain relief.

Several international studies have indicated that TAP block can significantly reduce postoperative pain scores and opioid consumption, particularly in abdominal surgeries. However, most of these studies are either retrospective or conducted outside the local context. In Pakistan, limited data exists, and the use of TAP block is not yet widespread or standardized in clinical practice.

This randomized controlled trial (RCT) is designed to evaluate the efficacy of TAP block in adult patients undergoing open appendectomy at Jinnah Hospital, Lahore. The study will enroll 136 participants, who will be randomized into two equal groups:

Group A will receive a TAP block with 10 ml of 1% lignocaine and 10 ml of 0.5% bupivacaine administered under direct vision at the end of the surgery.

Group B will undergo the same surgical procedure without the TAP block.

All surgeries will follow a standardized open appendectomy technique using a gridiron or Lanz incision. The TAP block will be performed in the midaxillary line between the anterior superior iliac spine and the subcostal margin under direct vision.

Pain will be assessed using the Visual Analog Scale (VAS) at multiple time points postoperatively (12, 16, and 24 hours). Additional parameters such as duration of hospital stay, postoperative complications (e.g., nausea, vomiting, delayed mobilization), and overall patient satisfaction will also be recorded.

The results from this study will help determine whether TAP block should be recommended as part of standard postoperative analgesia for open appendectomy. If the TAP block is found to be effective, it may reduce reliance on opioids, improve recovery times, and enhance patient outcomes-supporting broader implementation in surgical practices, especially in public-sector hospitals across developing regions.

This study adheres to ethical standards, with approval from the institutional ethical review committee, and informed consent will be obtained from all participants.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Postoperative Pain
timeFrame: 12, 16, and 24 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: