A study on pain relief after vaginal surgery

Phase 1

Conditions: postoperative pain
MedDRA version: 17.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2014-004236-19-SE

Lead Sponsor: andstinget i Östergötland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Women between 18 and 70 years of age.
The patient is scheduled for primary posterior vaginal reconstructive surgery because of posterios vaginal wall prolapse or suboptimally healed tear from previous delivery injury including suture between muscle tendons in local anesthesia and sedation.
The woman can understand and express herself in Swedish.
The woman agrees to participate in the study after written and verbal information through the signature of the form informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Additional surgery planned while at the hospital for the operation.
Hypersensitivity to Ropivacaine, to other local anesthetics of the amide type, or to
sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.
Pregnancy
Hypovolemia
The woman is disabled and can’t be expected to be mobilized the day after surgery in the same way as non-disabled people.
The woman is mentally incapacitated to such an extent that she can’t complete the relevant questionnaires, understand the implications of participating in the study, or the patient's participation it may be ethically questionable if
The woman has severe mental illness or medication for severe mental illness. The responsible doctor considers it inappropriate that patient will be included in the study.
Women with chronic pelvic pain
Woman taking medication for severe pain with drugs other than paracetamol and NSAIDs, which can affect the outcome measure.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish whether pudendal block with ropivacain after posterior vaginal surgery is better than placebo against postoperative pain.<br><br>;Secondary Objective: To investigate whether the duration of and the experience of the hospital stay, need for additional pain relief, nausea, vomiting, micturition disturbances, and complications, recovery differ between the patients receiving ropivacain compared to receiving sodium chloride as pudendal blockade. To describe the levels of Hospital related anxiety and depression HADand correlate these to experience of pain. Can staff identify patients with high levels of HAD?;Primary end point(s): Worst pain during the first 6 postoperative hours measured on a 10-point visual analog scale;Timepoint(s) of evaluation of this end point: With predefined intervals during the first postoperative 6 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Length of hospital stay, given analgesics during the first 6 postoperative hours, VAS-assessed global experience of the care episode and nausea / vomiting, incidence of micturition disorders, time to breakthrough pain, number of days to recovery (normal ADL activity), incidence of reported complications, and the occurrence numbness or restricted movement in the legs;Timepoint(s) of evaluation of this end point: HAD is completed after informed consent is given and the operation is planned. The interval between planning and surgery is up to 6 months, normally within 2 months. <br>Pain, nausea, global impression of hospital stay and medication given is measured during the first postoperative 6 hours, if the patients wakes up during the night and the next day. <br>Days to recovery and occurrence of complications perceived by the patient is measured in a questionnaire 8 weeks after surgery as part of routine quality registration for gynecological surgery.