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

Ain Shams University

Status: Enrolling

Conditions: Gynecology

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05757011

FMASU MD 247/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

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

pre-sacral nerve block

Experimental group

Description:

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.

Treatment:

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