AppendicitisNCT06943456
Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane (TAP) Block
A study testing Transversus Abdominis Plane (TAP) Block for Postoperative Pain Management and Standard Open Appendectomy with Postoperative Pain Management in people with Appendicitis and Postoperative Pain, run by University of Health Sciences Lahore.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Appendicitis, Postoperative Pain
- What is being tested?
- Transversus Abdominis Plane (TAP) Block for Postoperative Pain Management and Standard Open Appendectomy with Postoperative Pain Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane Block
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.
Read more
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.
Read the 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.
- Conditions
- Appendicitis, Postoperative Pain
- Being tested
- Transversus Abdominis Plane (TAP) Block for Postoperative Pain Management, Standard Open Appendectomy with Postoperative Pain Management
- Medical subject headings
- Appendicitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane (TAP) Block for Postoperative Pain ManagementProcedure or surgery
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
Standard Open Appendectomy with Postoperative Pain ManagementProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Open Appendectomy with Postoperative Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12, 16, and 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafiz Rana Kamran Ijaz, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943456
- Sponsor's protocol ID
- Exp131
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane Block
- ClinicalTrials.gov ID
- NCT06943456
- Acronym / sponsor ID
- Exp131
- Conditions
- Appendicitis, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open Appendectomy with Transversus Abdominis Plane (TAP) Block | Experimental | Procedure: Transversus Abdominis Plane (TAP) Block for Postoperative Pain ManagementPatients 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. |
| Open Appendectomy without Transversus Abdominis Plane (TAP) Block | Active comparator | Procedure: Standard Open Appendectomy with Postoperative Pain ManagementPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus Abdominis Plane (TAP) Block for Postoperative Pain ManagementThe 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 | Procedure or surgery | Open Appendectomy with Transversus Abdominis Plane (TAP) Block |
| Standard Open Appendectomy with Postoperative Pain ManagementThe 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 | Procedure or surgery | Open Appendectomy without Transversus Abdominis Plane (TAP) Block |
Primary outcome
Postoperative Pain
Time frame: 12, 16, and 24 hours post-surgery
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane (TAP) Block for Postoperative Pain Management and Standard Open Appendectomy with Postoperative Pain Management in people with Appendicitis and Postoperative Pain, run by University of Health Sciences Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafiz Rana Kamran Ijaz, MS General Surgery (0331-4745037, beekeeperrkrajput@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 12, 16, and 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.