Dexmedetomidine Versus Ketamine in TAP Block for Postoperative Analgesia After Total Abdominal Hysterectomy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age25-60
SponsorBangladesh Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective total abdominal hysterectomy
ASA physical status I-II
Age 25-60 years
Disqualifiers
Allergy to local anaesthetics
Patient refusal
Local infection/inflammation at block site
Anatomical deformity
Trial design
Design model
Parallel
Treatments tested in this trial
TAP block using Dexmedetomidine & Bupivacaine
DrugThe study intervention consists of administering 0.25% bupivacaine combined with dexmedetomidine 0.5 microgram/kg as an adjuvant.
TAP block using Ketamine Hydrochloride and Bupivacaine
DrugKetamine hydrochloride 1 mg/kg administered as an adjuvant with 0.25% bupivacaine during ultrasound-guided bilateral TAP block.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Bupi-DexActive comparator 1 intervention
Group B: Bupi-KetActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total postoperative morphine consumption in miligram (mg)
Total morphine sulfate consumption in mg during the first 24 postoperative hours.
Time frame
First 24 postoperative hoursSecondary outcomes
1
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.
Time frame
2, 4, 6, 12, and 24 hours after surgery2
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.
Time frame
First 24 hours after surgery3
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.
Time frame
Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery4
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.
Time frame
Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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