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

Gynecology Clinical Trial

Official title:

the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy: a Triple Blind Placebo Controlled RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757011
• Other study ID #: FMASU MD 247/2020
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2020
• Est. completion date: August 10, 2023

Study information

• Verified date: March 2023
• Source: Ain Shams University
• Contact: Rana M Wagdy, Lecturer
• Phone: 01011431780
• Email: Ranawagdy5[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gynecology
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	? 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	? 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