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.
NCT07368075 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2026-01-26
Summary
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
Conditions
- Post Operative Analgesia
- Opioid Sparing Anaesthesia
- Hypotension, Controlled
- Bradycardia
- Stoma Reversal Procedure
Interventions
- DRUG
-
TAP Block with Ropivacaine+Dexamethasone
With the patient with proper positioning the skin will be disinfected and the transducer positioned. A needle is placed deep to the fascia separating the internal oblique muscle from the transversus abdominis muscle. The needle entry point will be anesthetized with 20 mL 0.25% Rupivacane plus dexamethasone 4 mg. The local anesthetic spreads in this plane, blocking the sensory nerves (like iliohypogastric and ilioinguinal) that run along the abdominal wall.
- DRUG
-
TAP Block with Ropivacaine+Dexmedetomidine
With the patient with proper positioning the skin will be disinfected and the transducer positioned. A needle is placed deep to the fascia separating the internal oblique muscle from the transversus abdominis muscle. The needle entry point will be anesthetized with 20 mL 0.25% Rupivacane plus dexamedetomidine 0.25ug/kg. The local anesthetic spreads in this plane, blocking the sensory nerves (like iliohypogastric and ilioinguinal) that run along the abdominal wall
Sponsors & Collaborators
-
Sahiwal medical college sahiwal
lead OTHER_GOV
Principal Investigators
-
Adeel Riaz, MD · Sahiwal medical college sahiwal
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-22
- Primary Completion
- 2025-10-25
- Completion
- 2026-01-15
Countries
- Pakistan
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