Menu
Enrolling by invitation NCT07513012

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

No phase Interventional Post Operative Pain Control PONV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine, Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine.
Who it may be relevant to
Registry conditions: Post Operative Pain Control, PONV. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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:

1. 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. 2. 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. 3. 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. 4. 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? 5. 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. 6. 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.

Interventions

  • Procedure Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine
    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 a
  • Procedure Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine
    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

Primary outcome measures

  • 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 amount of postoperative IV opioids required as rescue analgesia in first 24 hrs [Time frame: From end of surgery up to 24 hours postoperatively.]
Secondary outcome measures (1)
  • Frequency of Postoperative nausea and vomiting (PONV) [Time frame: From the end of surgery to the end of treatment at 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Pakistan · 1 center
  • King Edward Medical University/ Mayo Hospital, Lahore. — Lahore

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 18428988

Identifiers

NCT: NCT07513012 · No.803/RC/KEMU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗