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 | Completed Phase 2 DMC

• 1 other identifier: 213/IRB
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Opioid Sparing Anaesthesia; Hypotension, Controlled; Bradycardia; Stoma Reversal Procedure; Post Operative Analgesia

Outcome Measures

Primary Outcomes (1)

• Post op Analgesia Effectiveness

  Duration of Post Op Analgesia

  Up to 24 hours

Secondary Outcomes (1)

• Opioid sparing Effect

  24 hours

Study Arms (2)

Group Ropivacaine+Dexamethasone

OTHER

patients will receive TAP block with 20 mL 0.25% Rupivacane+dexamethasone 4 mg

Drug: TAP Block with Ropivacaine+Dexamethasone

Group Ropivacaine+Dexmedetomidine

OTHER

patients will receive TAP Block with 20 mL of 0.25% ropivicaine+dexmedetomidine 0.25ug/kg

Drug: TAP Block with Ropivacaine+Dexmedetomidine

Interventions

TAP Block with Ropivacaine+Dexmedetomidine DRUG

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

Group Ropivacaine+Dexmedetomidine

TAP Block with Ropivacaine+Dexamethasone DRUG

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.

Group Ropivacaine+Dexamethasone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age limit: 18-60 years
• Gender of patient i.e., male or female.
• Patients listed for abdominal surgeries
• American Society of Anesthesiologists (ASA) the status of I or II

You may not qualify if:

• Patients with history of drug allergy.
• Patients with liver disease, kidney disease, cardiac disease or sickle cell anemia,severe preeclampsia CNS disorder on history. Clinical and laboratory assessment
• American Society of Anesthesiologists (ASA status III or IV)
• Patients with morbid obesity 5, Raynaud's disease
• \. Patients on adrenoceptor agonists or antagonists or narcotics before the operation

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead

Study Sites (1)

Sahiwal Medical College

Sāhīwāl, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Conditions

Hypotension; Bradycardia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adeel Riaz, MD

  Sahiwal medical college sahiwal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Anaesthetist

Model Details: Group I patients will receive TAP block with 20 mL 0.25% Rupivacane plus dexamethasone 4 mg at the end of surgery on surgical side. Group II patients will receive 20 mL of 0.25% ropivacaine plus dexmedetomidine 0.25ug/kg body weight at the end of surgery on surgical side

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 26, 2026
• Study Start: July 22, 2024
• Primary Completion: October 25, 2025
• Study Completion: January 15, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: February 2026

Locations

PA (1)