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

NCT06531603 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: IRB29
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain; Bradycardia; Hypotension; Nausea; Vomiting

Keywords

Bupivacaine; Dexmedetomidine; Post operative analgesia; Abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  Time from procedure to requirement of rescue analgesia

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

Secondary Outcomes (5)

• Opioid sparing

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

• Blood pressure

  Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively

• Hear rate

  Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs

• Neausea

  Every 30 minutes for 4 hrs then 2hrly for 24 hrs

• Vomiting

  Every 3 minutes for first 4 hrs then 2hrly for 24 hrs

Study Arms (2)

Bupivacaine group

EXPERIMENTAL

Patients receiving Bupivacaine plus placebo for wound infiltration after abdominal surgery for pain control.

Drug: bupivacaine wound infilteration

Bupivacaine plus Dexmedetomidine group

EXPERIMENTAL

Patients receiving Bupivacaine plus Dexmedetomidine for wound infiltration after abdominal surgery for pain control.

Drug: Bupivacaine plus dexmedetomidine wound infilteration

Interventions

bupivacaine wound infilteration DRUG

drug was given at the end of surgery

Also known as: LA infiltration

Bupivacaine group

Bupivacaine plus dexmedetomidine wound infilteration DRUG

drug was given at the end of surgery

Also known as: LA + Dex infiltration

Bupivacaine plus Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• 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) status of I or II

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead

Study Sites (1)

Sahiwal Medical College

Sahiwal, Punjab Province, 57000, Pakistan

Location

Related Publications (13)

• Chen J, Zhou JQ, Chen ZF, Huang Y, Jiang H. Efficacy and safety of dexmedetomidine versus propofol for the sedation of tube-retention after oral maxillofacial surgery. J Oral Maxillofac Surg. 2014 Feb;72(2):285.e1-7. doi: 10.1016/j.joms.2013.10.006. Epub 2013 Oct 25.

  PMID: 24438599 RESULT

• Champaneria R, Shah L, Geoghegan J, Gupta JK, Daniels JP. Analgesic effectiveness of transversus abdominis plane blocks after hysterectomy: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2013 Jan;166(1):1-9. doi: 10.1016/j.ejogrb.2012.09.012. Epub 2012 Oct 4.

  PMID: 23041302 RESULT

• Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.

  PMID: 21851346 RESULT

• Brogi E, Kazan R, Cyr S, Giunta F, Hemmerling TM. Transversus abdominal plane block for postoperative analgesia: a systematic review and meta-analysis of randomized-controlled trials. Can J Anaesth. 2016 Oct;63(10):1184-1196. doi: 10.1007/s12630-016-0679-x. Epub 2016 Jun 15.

  PMID: 27307177 RESULT

• Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.

  PMID: 22546966 RESULT

• Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2.

  PMID: 24882606 RESULT

• Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005.

  PMID: 16436839 RESULT

• Ayad S, Babazade R, Elsharkawy H, Nadar V, Lokhande C, Makarova N, Khanna R, Sessler DI, Turan A. Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15;11(4):e0153675. doi: 10.1371/journal.pone.0153675. eCollection 2016.

  PMID: 27082959 RESULT

• Ard JL Jr, Bekker AY, Doyle WK. Dexmedetomidine in awake craniotomy: a technical note. Surg Neurol. 2005 Feb;63(2):114-6; discussion 116-7. doi: 10.1016/j.surneu.2004.02.029.

  PMID: 15680647 RESULT

• Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. doi: 10.1097/00000539-200208000-00042.

  PMID: 12145072 RESULT

• Altuntas G, Akkaya OT, Ozkan D, Sayin MM, Balas S, Ozlu E. Comparison of Intraabdominal and Trocar Site Local Anaesthetic Infiltration on Postoperative Analgesia After Laparoscopic Cholecystectomy. Turk J Anaesthesiol Reanim. 2016 Dec;44(6):306-311. doi: 10.5152/TJAR.2016.75983. Epub 2016 Dec 1.

  PMID: 28058142 RESULT

• Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.

  PMID: 22286518 RESULT

• Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.

  PMID: 23811424 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Bradycardia; Hypotension; Nausea; Vomiting

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• M. Shahid, FCPS

  Sahiwal medical college sahiwal

  PRINCIPAL INVESTIGATOR

• A. 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
• Masking Details: Both patients and assessor were unaware of interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: August 1, 2024
• Study Start: February 20, 2022
• Primary Completion: January 20, 2023
• Study Completion: April 20, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)