- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01677143
Pre-emptive Local Anaesthesia in Gynecological Laparoscopy
Study Overview
Detailed Description
The study design is prospective, randomized, and double-blinded with parallel assignments. It will compare pre-emptive incisional injection of bupivacaine, 5 mg/ml, with a placebo injection (saline). The clinically relevant comparison should probably be between injection of local anaesthetics and no injection at all. However a study design like that would make blinding impossible and probably not acceptable as a research design for a study which aims to be published.
The aim of the study is to test if pre-emptive injection of long-lasting, local anaesthetics reduces post-operative pain. As local anaesthetics are already implemented in our routine, the hypothesis is that it has a positive effect by reducing postoperative pain. The null hypothesis is that there is no difference between local anaesthetics and placebo.
The recruitment of patients will be from our daily surgery, and consecutive patients who are eligible for day-case, laparoscopic surgery will be asked to participate.
To have a clinically important reduction of post-operative pain a difference of 2 units on a 0-10 numerical rating scale (NRS) is chosen for the sample size calculation. A smaller difference in pain score is not considered clinically relevant in our opinion. With a power of at least 80% this gives 20 patients in total, 10 in each arm. The power calculation was done by statistician S. Johnsen at the University of Surrey. We will include 24 patients altogether to cover for any losses to follow-up. The drop-out rates in clinical trials are usually estimated at 20 %, which would give 25 patients to be included (20/ (1-0.2) = 25). This study has, however, a very short follow-up period, so the drop-out rate is expected to be smaller. Drop-outs will be recorded and accounted for.
24 participants will be randomized in blocks of 6 patients. Block randomization is chosen to avoid pooling by chance.
All procedures will be done by one surgeon. This might be a subject for criticism as one can say that the results in the study are only true for one surgeon in a particular setting. But the need for standardization is very important in studies like this, as pointed out by Wilder-Smith (Wilder-Smith, O. H. 2000).
The time of the randomization is identified as the breakage of the study drug vial. If a potential candidate is found to satisfy any exclusion criteria or withdraws the consent before the vial is opened, the patient is not randomised. The study ID number and the study drug vial will be made available for the next potential candidate.
If a potential candidate is excluded for any reason after the breakage of the vial but before the completion of the injection of the study drug, the study ID number will be coded as Protocol Violation and excluded from the statistical analyses.
The patient, nursing staff and the surgeon will all be blinded to the substance injected.
Infiltration in the primary, umbilical site will be blind, but as close to the fascia as possible. The secondary port infiltrations will be done under visual guidance from the laparoscope, in the fascia and close to the peritoneum. Bupivacaine in a concentration of 5 mg/ml will be used and 5 ml of the solution will be injected at each port site. The patients who get placebo will get 5 ml of physiologic saline injected at each port site.
The primary outcome of the study will be movement-evoked pain (MEP) 5 hours after surgery, as half-life of bupivacaine is 4-6 hours. Movement-evoked pain is the most important outcome measure, because the goal is to get the patient back to normal, daily activities as soon as possible. Trials measuring both movement evoked pain and pain at rest (PAR) suggests that MEP is much more intense than PAR postoperative (Srikandarajah et al, 2011). Pain will be measured on a 10 cm long Numerical Rating Scale (NRS) where 0 cm is no pain and 10 cm is severe pain. NRS is validated as a good tool for pain measurement at different ages and education levels (Gagliese et al, 2005).
Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative, and use of rescue analgesics. Pain at rest must, of course, be recorded before movement evoked pain.
The pain scoring will be done by the patient with help from the nurses at the ward at 2 and 5 hours postoperative, and both will be blinded to which arm the patient is in.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Stavanger, Norway, 4068
- Stavanger University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women ≥18 years of age
- Planned day-case laparoscopic surgery
- Signed Written Informed Consent
Exclusion Criteria:
- ASA score 3-6
- Chronic pain/ Regular use of analgesics
- Inability to understand Norwegian language
- Drug or alcohol abuse
- Inability to understand or sign the Written Informed Consent form
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: bupivacaine
Injection of 5 ml bupivacaine, 5mg/ml in each port site.
|
5 ml in trocar area
Other Names:
|
Placebo Comparator: Placebo
Injection of 5 ml saline in each port site.
|
5 ml in trocar area
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative movement-evoked pain
Time Frame: 5 hours postoperative
|
The primary outcome of the study will be movement-evoked pain (MEP) 5 hours after surgery, as half-life of bupivacaine is 4-6 hours.
Movement-evoked pain is the most important outcome measure, because the goal is to get the patient back to normal, daily activities as soon as possible.
|
5 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain at rest
Time Frame: 2 and 5 hours postoperative
|
Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative.
|
2 and 5 hours postoperative
|
Rescue analgetics
Time Frame: 5 hours postoperative
|
Use of rescue analgesics postoperative.
|
5 hours postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Caroline Ravndal, MD, Helse Stavanger HF
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUS2012CMR01
- 2012-002356-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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