NCT07368075

To Compare Post-op Analgesic Effectiveness of Ropivicaine+Dexamethasone and Ropivacane+Dexmetomidine in TAP Block in Stoma Reversal Under GA in Terms of Duration of Analgesia.

Completed Phase 2, PHASE3 Last updated 26 January 2026

What this trial tests

Phase 2, PHASE3 trial testing TAP Block with Ropivacaine+Dexamethasone in Post Operative Analgesia in 86 participants. Completed in 15 January 2026.

Timeline

22 July 2024

Primary endpoint
25 October 2025

15 January 2026

Quick facts

Lead sponsor	Sahiwal medical college sahiwal
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	86
Start date	22 July 2024
Primary completion	25 October 2025
Estimated completion	15 January 2026
Sites	1 location across Pakistan

Drugs / interventions tested

• TAP Block with Ropivacaine+Dexamethasone — full drug profile →
• TAP Block with Ropivacaine+Dexmedetomidine — full drug profile →

Conditions studied

• Post Operative Analgesia — all drugs for Post Operative Analgesia →
• Opioid Sparing Anaesthesia — all drugs for Opioid Sparing Anaesthesia →
• Hypotension, Controlled — all drugs for Hypotension, Controlled →
• Bradycardia — all drugs for Bradycardia →

Sponsor

Sahiwal medical college sahiwal

Who can join

Adults 18 to 60, any sex, with Post Operative Analgesia or Opioid Sparing Anaesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Controlling pain is of major concern in intra-operative as well as post-operative period inpatients undergoing all surgeries especially abdominal surgeries.Adequate pain control in post-operative period directly effect patient's recovery and shortens the patient hospital stay consequently decreasing burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality and is a considerable problem worldwide.

Different modalities for pain control are used in post-operative period. Opioids are main stay of treatment in post-operative period but has significant side effect profile like dependence, nausea \& vomiting. Regional blocks like TAP (Trans Abdominal Plane) are now a days being used as post operative analgesia in abdominal surgeries.

The randomized control trial of Comparison of Ropivacane 0.25% plus Dexamethasone and Ropivacane 0.25% plus Dexmedetomedine will be conducted at department of anaesthesia of Sahiwal teaching hospital Sahiwal for 12 months. 86 patients meeting the inclusion criteria will be categorized into two different groups using computer-generated random number table. All patients will undergo a pre-operative assessment on the day before surgery. Both Group will receive TAP block with studied drugs at the end of surgery. After surgery patient will be shifted to post-surgical ward and will be assessed for pain using visual analogue scale (VAS) and data will be collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variable will be presented with mean± SD. Comparison of quantitative variable between groups will be done using independent sample-t-test. Comparison of qualitative variable like (opioid sparing effect Nausea,vomiting,Bradycardia,Hypotension) will be presented with frequency and percentages. Data will be stratified on the basis of gender and age. Post-stratification chi-square test will be used to compare both groups for opioid sparing effect in each stratum with p-value≤0.05 as significant

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.