Clinical trial NCT05757011: the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy
Official title: the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy: a Triple Blind Placebo Controlled RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecology
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: ● 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
timeFrame: 1hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Gasser Elbishry, Professor
role: STUDY_CHAIR
References: