Ultrasound-Guided Transversalis Fascia Plane Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Time to the 1st rescue analgesia
Study Overview
Brief Summary
This study aims to compare the ultrasound-guided transversalis fascia plane (TFP) block and intrathecal morphine for postoperative analgesia in patients undergoing total abdominal hysterectomy (TAH).
Detailed Description
Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort. Postoperative pain, if not treated promptly, can impair the patient's ability to ambulate which may lead to adverse effects such as thromboembolism, myocardial ischemia, and arrhythmia.
Intrathecal opioids are synergistic with local anesthetics and intensify the sensory block without increasing the sympathetic block. Morphine, which is relatively less hydrophobic than other opioids, has a longer residence time in the cerebrospinal fluid and therefore may reach rostral sites over a longer period than other opioids.
Ultrasound-guided interfascial plane blocks are often used in multimodal analgesia regimens. Local anaesthetic injection into the transversalis fascia plane (TFP) anesthetizes the proximal branches of T12 and L1 which targeted in the plane between the transversus abdominis muscle and the transversalis fascia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 18 to 65 years.
- •American Society of Anesthesiology (ASA) physical status I-II.
- •Women undergoing total abdominal hysterectomy (TAH) under spinal anesthesia.
Exclusion Criteria
- •History of allergies to local anesthetics.
- •Local infection at the site of injection.
- •Bleeding disorders.
- •History of chronic use of analgesic.
- •Physical or mental conditions.
- •Hepatic, renal or cardiac disease.
- •Contraindication to spinal anesthesia.
Arms & Interventions
TFP group
Patients will receive spinal anesthesia (using 3.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.
Intervention: Transversalis fascia plane block (Other)
IM group
Patients will receive spinal anesthesia (using 3 mL of hyperbaric bupivacaine 0.5%) + (75 µg morphine diluted in 0.5ml saline) with sham block at the end of surgery.
Intervention: Morphine (Drug)
Outcomes
Primary Outcomes
Time to the 1st rescue analgesia
Time Frame: 24 hours postoperatively
Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).
Secondary Outcomes
- Total morphine consumption(24 hours postoperatively)
- Degree of pain(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
Investigators
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University