Postoperative PainPhase 4NCT07845643
Dexmedetomidine Versus Ketamine in TAP Block for Postoperative Analgesia After Total Abdominal Hysterectomy
A Phase 4 study testing TAP block using Dexmedetomidine & Bupivacaine and TAP block using Ketamine Hydrochloride and Bupivacaine in people with Postoperative Pain and Total Abdominal Hysterectomy, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Postoperative Pain, Total Abdominal Hysterectomy
- What is being tested?
- TAP block using Dexmedetomidine & Bupivacaine and TAP block using Ketamine Hydrochloride and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Oct 2026to 30 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for elective total abdominal hysterectomy
- ASA physical status I-II
- Age 25-60 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Bangladesh Medical University
Dhaka, 1000
Susmita Ghosh, +8801704557371, susmitaghosh300595@gmail.com
Susmita Ghosh
About this study
Official title: Dexmedetomidine Versus Ketamine as an Adjuvant to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Total Abdominal Hysterectomy
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.
Read more
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.
Read the detailed description
Postoperative pain following total abdominal hysterectomy is influenced by both somatic and visceral components. The abdominal wall incision contributes significantly to somatic pain, while pelvic tissue manipulation contributes to visceral pain. Effective perioperative analgesia is essential to facilitate recovery and reduce opioid-related adverse effects.
The transversus abdominis plane (TAP) block is an established regional anaesthesia technique that provides analgesia by depositing local anaesthetic within the fascial plane between the internal oblique and transversus abdominis muscles, thereby reducing transmission of nociceptive signals from the abdominal wall. However, the duration of analgesia achieved with local anaesthetic alone may be limited, leading to interest in the use of adjuvant medications to enhance and prolong analgesic effects.
Dexmedetomidine and ketamine have different pharmacological mechanisms that may contribute to improved analgesia when combined with local anaesthetics. Dexmedetomidine, an α2-adrenergic receptor agonist, may enhance peripheral nerve block effects through modulation of neuronal excitability and nociceptive transmission. Ketamine, through NMDA receptor antagonism, may reduce central sensitization and hyperalgesia. Although both agents have demonstrated analgesic benefits in regional anaesthesia, comparative evidence regarding their relative effectiveness as adjuvants in TAP block for patients undergoing total abdominal hysterectomy remains limited.
This study is designed to generate comparative evidence regarding the analgesic efficacy and safety profile of these two commonly used adjuvant agents when administered with bupivacaine in ultrasound-guided TAP block. The findings may contribute to optimizing multimodal analgesic strategies and improving postoperative recovery after major gynaecological surgery
- Conditions
- Postoperative Pain, Total Abdominal Hysterectomy
- Being tested
- TAP block using Dexmedetomidine & Bupivacaine, TAP block using Ketamine Hydrochloride and Bupivacaine
- Keywords
- Total Abdominal Hysterectomy, Dexmedetomidine, Ketamine, Postoperative analgesia, Transversus abdominis plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block using Dexmedetomidine & BupivacaineDrug
The study intervention consists of administering 0.25% bupivacaine combined with dexmedetomidine 0.5 microgram/kg as an adjuvant.
TAP block using Ketamine Hydrochloride and BupivacaineDrug
Ketamine hydrochloride 1 mg/kg administered as an adjuvant with 0.25% bupivacaine during ultrasound-guided bilateral TAP block.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: TAP block using Ketamine Hydrochloride and Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative morphine consumption in miligram (mg)
Total morphine sulfate consumption in mg during the first 24 postoperative hours.
Measured: First 24 postoperative hours
Secondary outcomes (8)
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain, and 10 indicates the worst imaginable pain. Pain scores will be recorded at rest and during movement at predefined postoperative time points. The NRS pain scores will be compared between the dexmedetomidine and ketamine groups following total abdominal hysterectomy.
Measured: 2, 4, 6, 12, and 24 hours after surgery
Time to First Rescue Analgesic Request
The time interval from completion of surgery to the first requirement of rescue analgesia (intravenous morphine sulfate) will be recorded and compared between the dexmedetomidine and ketamine groups. Rescue analgesia will be administered when the Numeric Rating Scale (NRS) pain score reaches ≥4.
Measured: First 24 hours after surgery
Heart Rate (HR)
Heart rate will be recorded before administration of the ultrasound-guided TAP block (baseline) and subsequently monitored after surgery. The changes in heart rate will be compared between the dexmedetomidine and ketamine groups to assess haemodynamic response following the intervention.
Measured: Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery
Systolic Blood Pressure (SBP)
Systolic blood pressure will be measured before administration of the ultrasound-guided TAP block (baseline) and during the postoperative period. Changes in systolic blood pressure will be compared between the dexmedetomidine and ketamine groups.
Measured: Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery
Diastolic Blood Pressure (DBP)
Diastolic blood pressure will be measured before administration of the ultrasound-guided TAP block (baseline) and during postoperative follow-up. Changes in diastolic blood pressure will be compared between the dexmedetomidine and ketamine groups.
Measured: Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery
Mean Arterial Pressure (MAP)
Mean arterial pressure will be recorded before administration of the ultrasound-guided TAP block (baseline) and during postoperative follow-up. Changes in mean arterial pressure will be compared between the dexmedetomidine and ketamine groups to assess haemodynamic stability.
Measured: Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery
Postoperative Nausea and Vomiting (PONV)
The occurrence of postoperative nausea and vomiting will be assessed and compared between the dexmedetomidine and ketamine groups. Data regarding postoperative nausea and vomiting episodes will be collected from the postoperative record sheet after completion of the 24-hour postoperative observation period.
Measured: Within 24 hours after surgery
Sedation Level (Ramsay Sedation Score)
Postoperative sedation level will be assessed using the Ramsay Sedation Score and compared between the dexmedetomidine and ketamine groups. The Ramsay Sedation Score is a 6-point ordinal scale ranging from 1 to 6, where 1 indicates an anxious, agitated, or restless patient and 6 indicates no response to stimulation. Higher scores indicate a greater level of sedation. The score will be recorded during the postoperative observation period.
Measured: 2, 4, 6, 12, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazi Mahzabin Arin, Bangladesh Medical University
- Investigators
- Md Shafiqul M Islam, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845643
- Sponsor's protocol ID
- BMU/2026/20/000011
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26397443Niesters 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.
PubMed 23432384Mansour 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.
PubMed 34754346Laskowski 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.
PubMed 21773855Almarakbi 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.
PubMed 24843325Abdallah 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.
PubMed 23587874Marhofer 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.
PubMed 23161360El-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.
PubMed 30122981Becker 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.
PubMed 17175824Hebbard 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.
PubMed 18020088Champaneria 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.
PubMed 23041302Abdallah 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.
PubMed 22286518Bhattacharjee 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.
PubMed 25190950Johns 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.
PubMed 22632762McDonnell 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.
PubMed 17961838
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Ketamine as an Adjuvant to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT07845643
- Acronym / sponsor ID
- BMU/2026/20/000011
- Conditions
- Postoperative Pain, Total Abdominal Hysterectomy
- Keywords
- Total Abdominal Hysterectomy, Dexmedetomidine, Ketamine, Postoperative analgesia, Transversus abdominis plane block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative pain following total abdominal hysterectomy is influenced by both somatic and visceral components. The abdominal wall incision contributes significantly to somatic pain, while pelvic tissue manipulation contributes to visceral pain. Effective perioperative analgesia is essential to facilitate recovery and reduce opioid-related adverse effects.
The transversus abdominis plane (TAP) block is an established regional anaesthesia technique that provides analgesia by depositing local anaesthetic within the fascial plane between the internal oblique and transversus abdominis muscles, thereby reducing transmission of nociceptive signals from the abdominal wall. However, the duration of analgesia achieved with local anaesthetic alone may be limited, leading to interest in the use of adjuvant medications to enhance and prolong analgesic effects.
Dexmedetomidine and ketamine have different pharmacological mechanisms that may contribute to improved analgesia when combined with local anaesthetics. Dexmedetomidine, an α2-adrenergic receptor agonist, may enhance peripheral nerve block effects through modulation of neuronal excitability and nociceptive transmission. Ketamine, through NMDA receptor antagonism, may reduce central sensitization and hyperalgesia. Although both agents have demonstrated analgesic benefits in regional anaesthesia, comparative evidence regarding their relative effectiveness as adjuvants in TAP block for patients undergoing total abdominal hysterectomy remains limited.
This study is designed to generate comparative evidence regarding the analgesic efficacy and safety profile of these two commonly used adjuvant agents when administered with bupivacaine in ultrasound-guided TAP block. The findings may contribute to optimizing multimodal analgesic strategies and improving postoperative recovery after major gynaecological surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupi-Dex | Active comparator | Drug: TAP block using Dexmedetomidine & BupivacaineParticipants allocated to this group will receive an ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block using bupivacaine combined with dexmedetomidine as an adjuvant. |
| Bupi-Ket | Active comparator | Drug: TAP block using Ketamine Hydrochloride and BupivacaineParticipants allocated to this group will receive an ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block with bupivacaine and ketamine hydrochloride as an adjuvant. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective total abdominal hysterectomy
- ASA physical status I-II
- Age 25-60 years
Key exclusion criteria (8 listed)
- Allergy to local anaesthetics
- Patient refusal
- Local infection/inflammation at block site
- Anatomical deformity
- Coagulopathy or bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP block using Dexmedetomidine & BupivacaineThe study intervention consists of administering 0.25% bupivacaine combined with dexmedetomidine 0.5 microgram/kg as an adjuvant. | Drug | Bupi-Dex |
| TAP block using Ketamine Hydrochloride and BupivacaineKetamine hydrochloride 1 mg/kg administered as an adjuvant with 0.25% bupivacaine during ultrasound-guided bilateral TAP block. | Drug | Bupi-Ket |
Primary outcome
Total postoperative morphine consumption in miligram (mg)
Time frame: First 24 postoperative hours
Total morphine sulfate consumption in mg during the first 24 postoperative hours.
8 secondary outcomes
Postoperative Pain Intensity
Time frame: 2, 4, 6, 12, and 24 hours after surgery
Time to First Rescue Analgesic Request
Time frame: First 24 hours after surgery
Heart Rate (HR)
Time frame: Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery
Systolic Blood Pressure (SBP)
Time frame: Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery
Diastolic Blood Pressure (DBP)
Time frame: Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery
Mean Arterial Pressure (MAP)
Time frame: Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery
Postoperative Nausea and Vomiting (PONV)
Time frame: Within 24 hours after surgery
Sedation Level (Ramsay Sedation Score)
Time frame: 2, 4, 6, 12, and 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 26397443Baeriswyl 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.
- Background: PubMed 23432384Niesters 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.
- Background: PubMed 34754346Mansour 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.
- Background: PubMed 21773855Laskowski 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.
- Background: PubMed 24843325Almarakbi 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.
- Background: PubMed 23587874Abdallah 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.
- Background: PubMed 23161360Marhofer 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.
- Background: PubMed 30122981El-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.
- Background: PubMed 17175824Becker 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.
- Background: PubMed 18020088Hebbard 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.
- Background: PubMed 23041302Champaneria 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.
- Background: PubMed 22286518Abdallah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Md Shafiqul M Islam study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAP block using Dexmedetomidine & Bupivacaine and TAP block using Ketamine Hydrochloride and Bupivacaine in people with Postoperative Pain and Total Abdominal Hysterectomy, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kazi Mahzabin Arin, MD (+8801754057689, kazimahzabinarin@bmu.ac.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative morphine consumption in miligram (mg) (time frame: First 24 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07845643, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.