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Following a hysterectomy, women tend to experience high levels of pain, and many require strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable numbing medication) which works by blocking pain signals. The aim of this study is to find out whether injections of ropivacaine during surgery can help provide effective pain relief after surgery.Women aged between 45 and 70 who are having a vaginal hysterectomy can participate in the trial. Participants are randomly allocated to one of two groups. Those in the first group are given injections of ropivacaine at the site of the wound and in the peritoneum (space in the body that holds the organs in the abdomen) and those in the second group are given injections of a saline fluid in the same places that offers no pain relief before the end of their surgery. Participants in both groups are then regularly asked to rate their pain levels up to 24 hours after surgery. In addition, the pain killers they receive and length of hospital stay are recorded. There is a chance that the participants who receive the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks of participating.
At end of the vaginal hysterectomy operation, the gynecologist will inject the uterosacral, cardinal ligaments, adnexal areas and the vaginal edge with 15 ml of either the ropivacaine solution or the placebo fluid in each side, then 20 ml will be instilled inside the peritoneum. Analgesia will be given on request after operation. Visual analogue score of 0 to 100 mm will be used to assess the degree of pain, with 0 indicating no pain and 100 indicating worst pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Participants are given ropivacaine (0.5%) at a total dose of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation as pre-emptive analgesia. |
|
| control group | Placebo Comparator | Participants are given a placebo in the form of fluid injection of saline (0.9%) at total of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | local anesthetic will be given locally at the site of operation to decrease the level of pain after operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain score | Pain is measured by the patient using the visual analogue score | At 2 hours post--operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in hours to get out of bed after operation | Time in hours to get out of bed after operation is measured by a nurse responsible for the patient | at 12 hours post--operatively |
| Hospital stay in days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain is measured by the patient using the visual analogue score | At half hour post-operatively |
| Pain score | Pain is measured by the patient using the visual analogue score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eman Omran, M.D. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banha University | Banhā | Qalyubia Governorate | 13518 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Drug | placebo fluid will be given at the site of operation locally |
|
Hospital stay in days is measured by a nurse
| Up to 4 weeks post-operatively |
| Total Narcotic dose (Nalbuphine) | Total Narcotic dose (Nalbuphine) is measured by a nurse | Up to 24 hours post--operatively |
| Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery | Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery is measured by a nurse | at 24 hours post-operatively |
| Proportion of patients with nausea and vomiting in the first 24 hours | Proportion of patients with nausea and vomiting in the first 24 hours is measured by a nurse | At 24 hours post--operatively |
| Time spent in the post-anesthesia care unit | Time spent in the post-anesthesia care unit is measured by a nurse | Up to 24 hours post--operatively |
| At one hour post-operatively |
| Pain score | Pain is measured by the patient using the visual analogue score | At 4 hours post-operatively |
| Pain score | Pain is measured by the patient using the visual analogue score | At 8 hours post-operatively |
| Pain score | Pain is measured by the patient using the visual analogue score | At 12 hours post-operatively |
| Pain score | Pain is measured by the patient using the visual analogue score | At 24 hours post-operatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |