Ultrasound-guided Sacral Erector Spinae Plane Block as a Sole Anesthetic Technique Versus Saddle Block in Hemorrhoidectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.
Study Overview
Brief Summary
Study interventions:
The patients will be randomized into two equal groups, Group A and Group B.
Group A: Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB)
Group B: Patients will receive Saddle block.
The surgical procedure will be performed by an experienced surgeon.
The outcome:
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 0, 2, 4, 6, 12, and 24 hours after the procedure. The secondary outcomes will include the cumulative doses of tramadol (50 mg intramuscular) to be repeated every 8 hours in case NRS score is more than four, the number of patients requiring rescue medication in the postoperative period.
Detailed Description
Study interventions:
The patients will be randomized into two equal groups using a computer-generated random numbers table, named Group A and Group B. An independent data manager, utilizing computer generated software, will be responsible for the randomization process. Patients will be assigned to the groups through sequentially numbered, sealed, opaque envelopes containing the computer-generated random numbers, which will be accessible only to the anesthesiologist performing the block. The subjects will be randomly allocated to one of the two groups.
Group A: Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB)
Group B: Patients will receive Saddle block.
Preoperatively, history taking, clinical examination and routine laboratory investigation will be performed, patients will be instructed to fast for 6 hours for solids and 2 hours for clear fluids. Upon arrival in the operation room, intravenous access will be established, and an acetated ringer's solution will be infused at a rate of 10ml/kg. ECG, noninvasive blood pressure and arterial oxygen saturation will be routinely monitored. The Numerical Rating Scale (NRS) will be used to assess pain intensity, and all study participants will be trained preoperatively to use the NRS pain score system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with American Society of anesthesiologists' physical status (ASA) I to II.
- •Aged 18 to 65 years.
- •Both sexes.
- •Patients scheduled for perianal surgeries (hemorrhoidectomy).
Exclusion Criteria
- •1- Patients with spinal malformation. 2-Patients with liver impairment. 3- Patients with renal impairment. 4-Patients younger than 18 years or older than 65 years. 5- Patients with hypersensitivity to one of the used drugs. 6- Coagulopathy disorders. 7- Patients who underwent hemorrhoidectomy before.
Arms & Interventions
SESPB
Intervention: Ultrasound guided sacral erector spinae plane block (SESPB) (Procedure)
Saddle
Intervention: Saddle block. (Procedure)
Outcomes
Primary Outcomes
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.
Time Frame: Twenty Four hours after the procedure
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.
Secondary Outcomes
No secondary outcomes reported
Investigators
riham fathy galal
Lecturer of anesthesia, intensive care and pain medicine
Ain Shams University