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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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 |
|
| pre-sacral nerve block | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy. | Procedure | pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| ● 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rana M Wagdy, Lecturer | Contact | 01011431780 | Ranawagdy5@gmail.com | |
| Gihan Elhawary, Professor | Contact | 01146666794 | dr.asmaa.r.mady@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gasser Elbishry, Professor | Ain Shams Maternity Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university | Recruiting | Cairo | 11511 | Egypt |
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