Evaluation of Efficacy of Ultrasound Guided Transversus Abdominis Plane Block in Multimodal Regimen for Postoperative Analgesia after Total Abdominal Hysterectomy done under Combined Spinal Epidural Anaesthesia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Duration of analgesia
Study Overview
Brief Summary
This study is a randomized, double blind, parallel group, evaluating efficacy of Ultrasound guided Transversus Abdominis Plane (TAP) block in multimodal regimen after total abdominal hysterectomy patients done under combined spinal epidural aneasthesia technique in India. Subjects randomized in to two groups, Control group will receive standard postoperative analgesic treatment while study group will receive standard postoperative analgesic treatment and TAP block. The primary outcome measure will be assessment of duration of analgesia postoperatively within 24 hours. Secondary outcomes will be epidural morphine consumption, pain severity using visual analogue scores, Incidence of nausea-vomiting, pruritus, sedation and respiratory depression, complication of TAP block, Adverse effect of drug and patient satisfaction at 0, 2, 4, 6, 8, 10, 12, 18 and 24 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •All patients undergoing total abdominal hysterectomy under combined spinal epidural anaesthesia after obtaining informed consent.
- •ASA grade I-III.
- •Total abdominal hysterectomy performed via lower abdominal transverse (Pfannenstiel) incision.
Exclusion Criteria
- •Patient refusal.
- •A history of drug allergy or local anaesthetic toxicity.
- •BMI >35kg/m2 (to limit maximum Ropivacaine dose to 3mg/kg) Contraindications to regional anaesthesia (bleeding diathesis, infection at the site of block and peripheral neuropathy) Change of anaesthetic technique to general anaesthesia.
- •Failure or complication in epidural catheter insertion.
Outcomes
Primary Outcomes
Duration of analgesia
Time Frame: 0,2,4,6,8,10,12,18 and 24 hr.
Secondary Outcomes
- Epidural morphine consumption.(Severity of pain.)