Dexmedetomidine Versus Ketamine in TAP Block for Postoperative Analgesia After Total Abdominal Hysterectomy

NCT07845643 | Not Yet Recruiting Phase 4

• 1 other identifier: BMU/2026/20/000011
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Total abdominal hysterectomy is associated with significant postoperative pain due to abdominal wall incision and tissue manipulation. Effective pain management after surgery helps improve patient comfort, early mobilization, and recovery while reducing the need for opioid medications and their related side effects. The transversus abdominis plane (TAP) block is a regional anaesthesia technique that provides pain relief by blocking sensory nerves supplying the abdominal wall. However, the duration of analgesia provided by local anaesthetic alone may be limited. Adding adjuvant drugs such as dexmedetomidine or ketamine may enhance and prolong the analgesic effect. This randomized controlled trial aims to compare the effectiveness of dexmedetomidine and ketamine as adjuvants to bupivacaine in ultrasound-guided bilateral TAP block for postoperative pain management following total abdominal hysterectomy. Participants undergoing elective total abdominal hysterectomy will be randomly assigned to receive either bupivacaine with dexmedetomidine or bupivacaine with ketamine during TAP block. Postoperative pain intensity, morphine consumption, time to first rescue analgesia, haemodynamic changes, sedation level and postoperative nausea and vomiting will be assessed during the first 24 hours after surgery. The findings of this study may help determine which adjuvant provides better postoperative analgesia when combined with bupivacaine for TAP block in patients undergoing total abdominal hysterectomy.

Conditions

Postoperative Pain; Total Abdominal Hysterectomy

Keywords

Total Abdominal Hysterectomy; Dexmedetomidine; Ketamine; Postoperative analgesia; Transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

• Total postoperative morphine consumption in miligram (mg)

  Total morphine sulfate consumption in mg during the first 24 postoperative hours.

  First 24 postoperative hours

Secondary Outcomes (8)

• Postoperative Pain Intensity

  2, 4, 6, 12, and 24 hours after surgery

• Time to First Rescue Analgesic Request

  First 24 hours after surgery

• Heart Rate (HR)

  Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery

• Systolic Blood Pressure (SBP)

  Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery

• Diastolic Blood Pressure (DBP)

  Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery

Study Arms (2)

Bupi-Dex

ACTIVE COMPARATOR

Participants allocated to this group will receive an ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block using bupivacaine combined with dexmedetomidine as an adjuvant.

Drug: TAP block using Dexmedetomidine & Bupivacaine

Bupi-Ket

ACTIVE COMPARATOR

Participants allocated to this group will receive an ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block with bupivacaine and ketamine hydrochloride as an adjuvant.

Drug: TAP block using Ketamine Hydrochloride and Bupivacaine

Interventions

TAP block using Dexmedetomidine & Bupivacaine DRUG

The study intervention consists of administering 0.25% bupivacaine combined with dexmedetomidine 0.5 microgram/kg as an adjuvant.

Bupi-Dex

TAP block using Ketamine Hydrochloride and Bupivacaine DRUG

Ketamine hydrochloride 1 mg/kg administered as an adjuvant with 0.25% bupivacaine during ultrasound-guided bilateral TAP block.

Bupi-Ket

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective total abdominal hysterectomy
• ASA physical status I-II
• Age 25-60 years

You may not qualify if:

• Allergy to local anaesthetics
• Patient refusal
• Local infection/inflammation at block site
• Anatomical deformity
• Coagulopathy or bleeding disorder
• Chronic pain syndrome
• Chronic opioid consumption (\>2 weeks)
• Severe cardiac, hepatic, renal, or psychiatric disorders

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (23)

• Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.

  PMID: 26397443 BACKGROUND

• Niesters M, Martini C, Dahan A. Ketamine for chronic pain: risks and benefits. Br J Clin Pharmacol. 2014 Feb;77(2):357-67. doi: 10.1111/bcp.12094.

  PMID: 23432384 BACKGROUND

• Mansour RF, Afifi MA, Abdelghany MS. Transversus Abdominis Plane (TAP) Block: A Comparative Study between Levobupivacaine versus Levobupivacaine plus Ketamine in Abdominoplasty. Pain Res Manag. 2021 Oct 31;2021:1762853. doi: 10.1155/2021/1762853. eCollection 2021.

  PMID: 34754346 BACKGROUND

• Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic review of intravenous ketamine for postoperative analgesia. Can J Anaesth. 2011 Oct;58(10):911-23. doi: 10.1007/s12630-011-9560-0. Epub 2011 Jul 20.

  PMID: 21773855 BACKGROUND

• Almarakbi WA, Kaki AM. Addition of dexmedetomidine to bupivacaine in transversus abdominis plane block potentiates post-operative pain relief among abdominal hysterectomy patients: A prospective randomized controlled trial. Saudi J Anaesth. 2014 Apr;8(2):161-6. doi: 10.4103/1658-354X.130683.

  PMID: 24843325 BACKGROUND

• Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.

  PMID: 23587874 BACKGROUND

• Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.

  PMID: 23161360 BACKGROUND

• El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018 Aug 8;11:35-44. doi: 10.2147/LRA.S154512. eCollection 2018.

  PMID: 30122981 BACKGROUND

• Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006 Fall;53(3):98-108; quiz 109-10. doi: 10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.

  PMID: 17175824 BACKGROUND

• Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

  PMID: 18020088 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Bhattacharjee S, Ray M, Ghose T, Maitra S, Layek A. Analgesic efficacy of transversus abdominis plane block in providing effective perioperative analgesia in patients undergoing total abdominal hysterectomy: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):391-6. doi: 10.4103/0970-9185.137274.

  PMID: 25190950 BACKGROUND

• Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.

  PMID: 22632762 BACKGROUND

• McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

  PMID: 17961838 BACKGROUND

• Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

  PMID: 11576144 BACKGROUND

• Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.

  PMID: 30877144 BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

  PMID: 16698416 BACKGROUND

• Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.

  PMID: 11020770 BACKGROUND

• Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.

  PMID: 14667752 BACKGROUND

• Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4.

  PMID: 19588344 BACKGROUND

• Carugno J, Fatehi M. Abdominal Hysterectomy (Archived). 2023 Jul 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564366/

  PMID: 33232036 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Md Shafiqul M Islam

  Bangladesh Medical University

  STUDY DIRECTOR

Central Study Contacts

Kazi Mahzabin Arin, MD

CONTACT

+8801754057689; kazimahzabinarin@bmu.ac.bd

Md Shafiqul Islam, MD

CONTACT

+8801712116650; mdsislam@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)