the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy

Not Applicable

Recruiting

• Conditions: Gynecology
• Interventions: Procedure: pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.

• Registration Number: NCT05757011
• Lead Sponsor: Ain Shams University

Brief Summary

40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to:

Group A Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered.

While patients randomized to group B will undergo TLH with pre-sacral nerve block.

Detailed Description

40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to: Group A Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered , then the uterus will be removed, and the operation will be terminated

While patients randomized to group B will undergo TLH with pre-sacral nerve block as follows:

Uterosacral nerve block will be performed before the removal of uterus and the closure of vaginal cuff, and before the removal of trocars from abdominal cavity, insertion of 6-inch 22G needle 2 to 3 cm below the umbilicus, injection of the SHP area which situated anterior to L5-S1 vertebral bodies, Caudal to the bifurcation of the abdominal aorta with 30 ml 0.25% bupivacaine (Marcaine®0.25% , Astra Zeneca, Egypt) will be administered. Following the injection of local anesthetic, patient will be placed from Trendelenburg position to horizontal position. The we will remove the uterus and trocars , and the operation will be terminated.

Data will be recorded in a case report form (CRF) and statistical analysis will be done.

Study Timeline

• Study Start: 2020-01-05
• Study First Submitted: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-07
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-07-10
• Study Completion: 2023-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women undergoing elective total laparoscopic hysterectomy Body mass index less than 29 Kg/m2

Exclusion Criteria

• Previous presacral neurectomy
• Concurrent surgical procedure other than salpingectomy and/or oophorectomy
• Chronic narcotic consumption Inability to provide consent
• Patients with contraindication to laparoscopic surgery (e.g. severe cardiopulmonary dysfunction).
• Bleeding tendency (e.g. patient on anticoagulants, platelets disorders)
• Intra-abdominal adhesions (due to previous abdominal surgery e.g. myomectomy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-sacral nerve block	pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.	Uterosacral nerve block will be performed before the removal of uterus and the closure of vaginal cuff, and before the removal of trocars from abdominal cavity, insertion of 6-inch 22G needle 2 to 3 cm below the umbilicus, injection of the SHP area which situated anterior to L5-S1 vertebral bodies, Caudal to the bifurcation of the abdominal aorta with 30 ml 0.25% bupivacaine (Marcaine®0.25% , Astra Zeneca, Egypt) will be administered. Following the injection of local anesthetic, patient will be placed from Trendelenburg position to horizontal position. The we will remove the uterus and trocars , and the operation will be terminated. Data will be recorded in a case report form (CRF) and statistical analysis will be done.
Placebo	pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.	Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered , then the uterus will be removed, and the operation will be terminated

Primary Outcome Measures

Name	Time	Method
● Post-operative pain 1 hour after the procedure will be assessed by visual analogue scale (VAS). (range will be from zero (no pain) to 10	1hour	● Post-operative pain 1 hour after the procedure will be assessed by visual analogue scale (VAS). (range will be from zero (no pain) to 10

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt