the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo 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 |
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.
|
| Experimental: pre-sacral nerve block 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- ● 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
Eligibility Criteria
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
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Chronic narcotic consumption Inability to provide consent
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Patients with contraindication to laparoscopic surgery (e.g. severe cardiopulmonary dysfunction).
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Bleeding tendency (e.g. patient on anticoagulants, platelets disorders)
-
Intra-abdominal adhesions (due to previous abdominal surgery e.g. myomectomy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ain Shams university | Cairo | Egypt | 11511 |
Sponsors and Collaborators
- Ain Shams University
Investigators
- Study Chair: Gasser Elbishry, Professor, Ain Shams Maternity Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FWA00017585