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Post Operative Pain ControlNCT07513012

Effectiveness of Unilateral Transversus Abdominis Plane (TAP) Block vs Bilateral TAP Block in Patients Undergoing Laparoscopic Cholecystectomy.

A study testing Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine and Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine in people with Post Operative Pain Control and PONV, run by King Edward Medical University at 1 site in Pakistan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

In this study, patients undergoing laparoscopic cholecystectomy will be randomly divided into 2 groups after consent. Group A patients will be administered a one-sided (right unilateral) regional TAP block and group B patients will be administered the same block on both sides (bilateral) and the effects in terms of… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Post Operative Pain Control, PONV
What is being tested?
Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine and Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 sitePakistan
Study dates
4 Nov 2025to 4 Apr 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both genders between 18-80 years with symptomatic gallstone disease.
  • Diagnosed patients that are fit for laparoscopic cholecystectomy, having ASA status of I, II or III).
  • No documented allergies or adverse reactions to local anesthetics used.
  • Patients consenting to participate in the study.

Who cannot join

  • Non consenting individuals.
  • Active skin infection at TAP block site i.e. triangle of petit.
  • Patients with coagulopathies.
  • Patients with chronic pain disorders and chronic use of analgesics.
  • Patients with chronic liver and kidney diseases.
  • Patients with alcohol, opioid or other substance addiction.
  • History of previous major elective or emergency abdominal surgery.
  • Pregnant and breast feeding women.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan1 site
  • King Edward Medical University/ Mayo Hospital, Lahore.

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Comparison of Efficacy of Unilateral Transversus Abdominis Plane (TAP) Block Versus Bilateral Transversus Abdominis Plane (TAP) Block in Patients Undergoing Laparoscopic Cholecystectomy.

In this study, patients undergoing laparoscopic cholecystectomy will be randomly divided into 2 groups after consent. Group A patients will be administered a one-sided (right unilateral) regional TAP block and group B patients will be administered the same block on both sides (bilateral) and the effects in terms of post surgery pain during the 1st 24 hours, nausea vomiting, and the need and dosage of intravenous analgesic and antiemetic will be studied to see whether one technique is superior to the other or not.

Read the detailed description
  1. INTRODUCTION: Laparoscopic cholecystectomy (LC) is the gold standard procedure for individuals with symptomatic gallstone disease. Although LC is a minimally invasive procedure with very less morbidity, early post-operative pain still a significant issue.1 Adequate pain control is therefore necessary to improve clinical outcomes, patient satisfaction and to ensure early mobility of the patients. Pain after laparoscopic cholecystectomy can be broadly classified into 3 categories: (a) somatic pain due to skin incisions; (b) Visceral pain due to intra-abdominal gallbladder dissection and; (c) reflected visceral pain or referred pain to the tip of right shoulder. Out of these, the somatic pain from port site incisions is the most troublesome for patients. Various methods have been tried to reduce post-operative pain after LC, one of which is the Transversus abdominis plane (TAP) block. TAP block is a regional anesthesia technique used for post-operative analgesia in abdominal surgeries. TAP block was first described by Rafi et al in 2001, as a regional block, in which local anesthesia is injected through triangle of petit to achieve analgesia of the T6 to L1 thoracolumbar nerves as they pass through the plane between internal oblique and transversus abdominis muscles.5,7,8 This blocks the sensory nerves in the anterolateral abdominal wall. Unilateral TAP block has been used as a part of multimodal analgesia in LC, with favorable results. However, half of the port site incisions in LC are located in the midline, i.e. the subxiphoid epigastric and the umblical ports. So, whether a unilateral TAP block alone provides adequate analgesia or not, cannot be stated as a fact. Although literature compares unilateral vs bilateral TAP in a variety of different surgical procedures, such as cesarean section and laparoscopic shockwave lithotripsy10,11 only one study is available to compare unilateral TAP versus bilateral TAP in LC. Thus, the rationale of this study is that more research needs to be done to compare unilateral and bilateral TAP blocks in LC so as to establish which of the two is more efficient in providing adequate analgesia and eliminating the need for post-operative intravenous opioids. This will help us to better understand the role of in TAP block in LC. It is expected that this will help in reducing the need and dosage for postoperative IV opioids thus reducing post-operative nausea and vomiting (PONV), improve patient satisfaction and allow early mobilization of the patient. Mayo hospital Lahore is one of the largest government sector hospitals of Punjab with a dedicated surgical facility well equipped to deal with large numbers of patients with symptomatic gallstones. This makes this hospital an ideal set-up for conducting this research.
  2. OBJECTIVE: Primary objective of this study is to compare unilateral and bilateral TAP blocks in terms of efficacy in terms of mean duration of postoperative analgesia and the need and amount of post- operative IV opioids needed. Secondary objectives include comparison of both blocks in terms of PONV, the need and amount of ondensetron, and patient satisfaction.
  3. OPERATIONAL DEFINITIONS:
  4. TRANVERSUS ABDOMINIS PLANE (TAP) BLOCK: Tap block is a regional block, where a local anesthetic is inserted into the triangle of petit in the plane between internal oblique and transversus abdominis muscles to block the neuronal afferents from T6-L1 spinal roots, which provide somatic supply to the anterolateral abdominal wall.
  5. TRIANGLE OF PETIT: An anatomical landmark in the posterolateral abdominal wall bounded anteriorly by the most posterior attachment of external oblique muscle, posteriorly by the most anterior attachment of lattismus dorsi muscle and inferiorly by the iliac crest. The floor of the triangle is formed by internal oblique muscle.
  6. POST-OPERATIVE PAIN: Post-operative pain is defined as the pain intensity reported by the patient following surgery, using the Visual Numerical Rating Scale (VNRS) at rest and after cough, assessed at predefined intervals. The VNRS is a numeric scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
  7. RESEARCH QUESTION: Is right unilateral TAP block equally effective as a bilateral TAP block in terms of decreasing post- operative pain and need for IV opioids in patients undergoing laparoscopic cholecystectomy?
  8. HYPOTHESIS: Bilateral TAP block is more efficacious than a right unilateral TAP block in preventing postoperative pain and need of IV opioids in patients undergoing laparoscopic cholecystectomy.
  9. NULL HYPOTHESIS:

There is no difference between a right unilateral TAP block and a bilateral TAP block in terms of post-operative pain and the need of IV opioids in patients undergoing laparoscopic cholecystectomy.

Being tested
Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine, Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine
Keywords
Transversus Abdominis Plane Block, TAP Block, Laparoscopic Cholecystectomy, Unilateral TAP Block, Bilateral TAP Block, Postoperative Pain, Postoperative Nausea and Vomiting, PONV, Regional Anesthesia
Medical subject headings
Postoperative Nausea and Vomiting, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaineProcedure or surgery

    TAP block is a regional anesthesia technique used for post-operative analgesia in abdominal surgeries. TAP block was first described by Rafi et al in 2001, as a regional block, in which local anesthesia is injected through triangle of petit to achieve analgesia of the T6 to L1 thoracolumbar nerves as they pass through the plane between internal oblique and transversus abdominis muscles. This blocks the sensory nerves in the anterolateral abdominal wall. Right Unilateral TAP block has been used as a part of multimodal analgesia in Lap chole (LC), with favorable results.

  • Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaineProcedure or surgery

    TAP block is a regional anesthesia technique used for post-operative analgesia in abdominal surgeries. TAP block was first described by Rafi et al in 2001, as a regional block, in which local anesthesia is injected through triangle of petit to achieve analgesia of the T6 to L1 thoracolumbar nerves as they pass through the plane between internal oblique and transversus abdominis muscles. This blocks the sensory nerves in the anterolateral abdominal wall. Bilateral TAP block can be used as a part of multimodal analgesia in Lap chole (LC), because two of the ports (epigastric and umbilical) in Lap chole are in the midline and hence receive sensory supply from both right and left side.

Study groups in NCT07513012
Study groupRoleWhat they receive
Group AActive comparatorRight unilateral TAP block
Receives: Procedure: Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine
Group BExperimentalBilateral TAP block
Receives: Procedure: Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean time to first request for rescue analgesia

    Time from completion of surgery to first request for rescue analgesia.

    Measured: Time from completion of surgery to first request for rescue analgesia till completion of 24 hrs

  2. The amount of postoperative IV opioids required as rescue analgesia in first 24 hrs

    Total amount of intravenous opioid analgesic (in mg) administered in the first 24 hours after surgery

    Measured: From end of surgery up to 24 hours postoperatively.

Secondary outcomes (1)
  1. Frequency of Postoperative nausea and vomiting (PONV)

    Frequency of postoperative nausea and/or vomiting within the first 24 hours after surgery.

    Measured: From the end of surgery to the end of treatment at 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study start4 Nov 2025
  3. Primary completion4 Apr 2026 (estimated)
  4. Study completion4 Apr 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sampling will be done using the RANDOM ALLOCATION SOFTWARE 2.0. Patients will be allocated to either group using computer generated sets of random allocation to groups A or B (right unilateral TAP block being group A and bilateral TAP blocks being group B). The group allocation will be done in advance of the start of study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07513012
Sponsor's protocol ID
No.803/RC/KEMU
Status last verified
Apr 2026
First submitted
23 Nov 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sahin AS, Ay N, Sahbaz NA, Akay MK, Demiraran Y, Derbent A. Analgesic effects of ultrasound-guided transverse abdominis plane block using different volumes and concentrations of local analgesics after laparoscopic cholecystectomy. J Int Med Res. 2017 Feb;45(1):211-219. doi: 10.1177/0300060516682883. Epub 2017 Jan 17.

    PubMed 28222631
  • Kendall JM. Designing a research project: randomised controlled trials and their principles. Emerg Med J. 2003 Mar;20(2):164-8. doi: 10.1136/emj.20.2.164. No abstract available.

    PubMed 12642531
  • Nimmaanrat S, Thepsuwan A, Tipchatyotin S, Jensen MP. Measuring pain intensity in older patients: a comparison of five scales. BMC Geriatr. 2024 Jun 25;24(1):556. doi: 10.1186/s12877-024-05127-6.

    PubMed 38918711
  • Choi S, Yoon SH, Lee HJ. Beyond measurement: a deep dive into the commonly used pain scales for postoperative pain assessment. Korean J Pain. 2024 Jul 1;37(3):188-200. doi: 10.3344/kjp.24069.

    PubMed 38769013
  • Elnabtity AM, Shabana WM. Unilateral versus bilateral ultrasound-guided transversus abdominis plane blocks during ureteric shock wave lithotripsy: A prospective randomized trial. Urol Ann. 2016 Jul-Sep;8(3):265-9. doi: 10.4103/0974-7796.184893.

    PubMed 27453645
  • Elhadad MA, Abdelrahman RK. Unilateral Versus Bilateral Ultrasound Guided Tap Block Effect on Postoperative Pain Control in CS. The Egyptian Journal of Hospital Medicine. 2023 Apr 1;91(1):4879-83

  • Ma J, Cassera MA, Spaun GO, Hammill CW, Hansen PD, Aliabadi-Wahle S. Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy. Ann Surg. 2011 Jul;254(1):22-7. doi: 10.1097/SLA.0b013e3182192f89.

    PubMed 21494123
  • Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.

    PubMed 18428988
  • Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

    PubMed 11576144
  • Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018.

    PubMed 28526156
  • Alsharari AF, Abuadas FH, Alnassrallah YS, Salihu D. Transversus Abdominis Plane Block as a Strategy for Effective Pain Management in Patients with Pain during Laparoscopic Cholecystectomy: A Systematic Review. J Clin Med. 2022 Nov 22;11(23):6896. doi: 10.3390/jcm11236896.

    PubMed 36498471
  • Ozciftci S, Sahiner Y, Sahiner IT, Akkaya T. Is Right Unilateral Transversus Abdominis Plane (TAP) Block Successful in Postoperative Analgesia in Laparoscopic Cholecystectomy? Int J Clin Pract. 2022 Apr 6;2022:2668215. doi: 10.1155/2022/2668215. eCollection 2022.

    PubMed 35685608
  • Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006231. doi: 10.1002/14651858.CD006231.

    PubMed 17054285
  • Peng K, Ji FH, Liu HY, Wu SR. Ultrasound-Guided Transversus Abdominis Plane Block for Analgesia in Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis. Med Princ Pract. 2016;25(3):237-46. doi: 10.1159/000444688. Epub 2016 Feb 16.

    PubMed 26885872

Questions about this trial

What is this clinical trial studying?

A study testing Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine and Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine in people with Post Operative Pain Control and PONV, run by King Edward Medical University at 1 site in Pakistan.

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 4 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean time to first request for rescue analgesia (time frame: Time from completion of surgery to first request for rescue analgesia till completion of 24 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07513012, which also lists 14 linked publications.

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 6 Apr 2026.

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