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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05757011
Enrollment
40
Registered
2023-03-07
Start date
2020-01-05
Completion date
2023-08-10
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecology

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.

Interventions

PROCEDUREpre-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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
● Post-operative pain 1 hour after the procedure will be assessed by visual analogue scale (VAS). (range will be from zero (no pain) to 101hour● 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

Countries

Egypt

Contacts

Primary ContactRana M Wagdy, Lecturer
Ranawagdy5@gmail.com01011431780
Backup ContactGihan Elhawary, Professor
dr.asmaa.r.mady@gmail.com01146666794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026