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NCT Number: NCT06531603

Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery

Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.

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Key information

Conditions

Post Operative Pain Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Hypotension Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vascular Diseases Vomiting

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sahiwal Medical College

Sahiwal, Punjab Province, 57000, Pakistan

About this study

This randomized controlled trial was conducted at Department of Anesthesia, Sahiwal Teaching Hospital, Sahiwal. After institutional review board (IRB) approval, computer-generated random number table was used to randomize the patients to two groups, one group received Bupivacaine plus placebo and the other group received Bupivacaine plus dexmedetomidine. A total of 64 patients met the inclusion criteria and were enrolled in the study in a 1:1. Informed written consent was obtained from all the patients before enrolling them in the study. All patients underwent a pre-operative assessment on the day before surgery. Both groups received wound infiltration with studied drugs at the end of surgery. After surgery patients were shifted to post-surgical ward and assessed for pain using visual analogue scale (VAS) and data was collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variables were presented with mean ±SD. Comparison of quantitative variable between groups was done using independent sample t-test. Comparison of qualitative variable like (Opioid sparing effect, Bradycardia, Hypotension, Nausea, Vomiting) was presented with frequency and percentages. Data was stratified on the basis of gender and age. Post-stratification chi-square test was used to compare both groups for opioid sparing effect in each stratum with p-value ≤0.05 as significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with history of drug allergy
  • Patients who undergone any analgesia in past 24 hr
  • Patients with liver disease, kidney disease, cardiac disease, sickle cell anemia, severe preeclampsia or CNS disorder on history, clinical and laboratory assessment
  • American Society of Anesthesiologists (ASA) status III or IV
  • Patients with morbid obesity 6, Raynaud's disease Patients on adrenoceptor agonists, antagonists or narcotics before the operation.

Treatment and study plan

bupivacaine wound infilteration

Drug

drug was given at the end of surgery

Other names: LA infiltration

Bupivacaine plus dexmedetomidine wound infilteration

Drug

drug was given at the end of surgery

Other names: LA + Dex infiltration

Primary outcomes

  1. Duration of analgesia

    Time frame: Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure

    Time from procedure to requirement of rescue analgesia

Secondary outcomes

  1. Opioid sparing

    Time frame: Total dose of nalbuhine consumption in 1st 24 hrs after procedure

    Total amount of opioid consumtion in the first 24 post procedure.

  2. Blood pressure

    Time frame: Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively

    Mean pressue will be measured

  3. Hear rate

    Time frame: Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs

    Heart rate will be measured

  4. Neausea

    Time frame: Every 30 minutes for 4 hrs then 2hrly for 24 hrs

    Felling of nasueas

  5. Vomiting

    Time frame: Every 3 minutes for first 4 hrs then 2hrly for 24 hrs

    Urge to vomit

Sponsors and collaborators

Lead sponsor

Sahiwal medical college sahiwal

Other Gov

Registry information

Official study title

Comparison of Postoperative Analgesic Effectiveness of Bupivacaine and Bupivacaine Plus Dexmedetomidine Wound Infiltration in Abdominal Surgeries Under General Anesthesia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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