Pain, Postoperative
Conditions
Brief summary
The investigators aim is to study the effect of pre-operative local anesthetic on post vaginal hysterectomy pain.
Detailed description
This is a double-blinded, randomized, controlled trial. Women who undergone elective vaginal hysterectomy and gave their informed consent were included. Exclusion criteria included additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine. Solutions of either Bupivacaine-Hydrochloride 0.5%, or Sodium-Chloride 0.9% as a placebo, were prepared prior to surgery, according to randomization. The chosen solution was injected before incision, as a modified paracervical block, and in each resection line (sacro-uterine and cardinal ligaments). The amount of fluid administered was 10 ml. When colporrhaphy was also performed, an additional 5 ml of solution were injected in the midline of the vaginal wall prior to each incision line. By utilizing the 10 cm Visual-analogue-scale (VAS) we examined the differences in post-operative pain at rest at 3, 8, and 24 hours, and during ambulation at 8 and 24 hours using multivariate linear regression models. We also assessed the differences in analgesics given at the different time points between the groups using multivariate negative binomial regression models.
Interventions
Local infiltration by Marcaine 0.5% Injectable Solution prior to incision
DRUGSodium Chloride 0.9%
Local infiltration by Sodium Chloride 0.9% prior to incision
Sponsors
Wolfson Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The surgeons, the pain assessing researchers, and the participating women will all be blinded to what the syringes contain.
Intervention model description
Drug group versus placebo group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Elective vaginal hysterectomy on benign indication
Exclusion criteria
additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at movement | 24 hours | Movement-evoked pain will be scored after the operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain at rest | 24 hours | Pain at rest will be scored with the woman lying in bed after the operation |
Countries
Israel
Outcome results
None listed