Laparoscopic Hysterectomy, Post Operative Pain, Referred Pain
Conditions
Keywords
shoulder pain, laparoscopic, analgesia
Brief summary
The goal of this randomized study looks at whether giving patients a medicine called acetazolamide (also called Diamox) before they have laparoscopic hysterectomy may decrease postoperative pain. Researchers will compare acetazolamide to a placebo or inactive drug, to see if acetazolamide helps the pain that may occur after surgery from the gas used in the abdomen during the laparoscopic procedure. Patients will be asked to rate their pain before surgery and after surgery through 24 hours.
Detailed description
Pain control following surgery is integral to surgical success, allowing faster recovery and return to function and increasing patient satisfaction. Minimally invasive surgery, such as laparoscopy, is becoming increasingly common as it involves smaller incisions and theoretically less discomfort. However, in order to perform laparoscopy, one must insufflate the abdomen with gas in order to create space in which to operate. The most commonly used gas today is carbon dioxide, as it is highly soluble and reduces the risk of air embolism compared to room air if absorbed. A consequence of using carbon dioxide is that it is converted to carbonic acid that can be irritating to the peritoneum and specifically the diaphragm, causing referred pain to the right subscapular (shoulder) region. Multiple strategies have been undertaken to help reduce this discomfort, one of which is using acetazolamide (a carbonic anhydrase inhibitor) to help reduce peritoneal acidification. Multiple studies have demonstrated an improvement in shoulder pain following preoperative administration in laparoscopic cholecystectomy, but studies evaluating use in pelvic surgery have had mixed results. The goal of this study is to add to this understanding and determine if acetazolamide is a useful adjunct to current pain control methods in laparoscopic gynecologic surgery.
Interventions
DRUGAcetazolamide 500 MG Extended Release Oral Capsule
Active Drug
DRUGPlacebo
Inactive Drug
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind
Intervention model description
randomized, double-blinded, controlled trial
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women * Ages 21-65 * undergoing total laparoscopic hysterectomy (TLH) for benign indications with or without bilateral salpingoophorectomy * undergoing total laparoscopic hysterectomy (TLH) for benign indications with or without cystoscopy
Exclusion criteria
* Allergy to acetazolamide or sulfonamides * Known electrolyte disturbances * Pregnancy * Kidney failure or creatinine \>1.5 * Diuretic or lithium use * Chronic obstructive pulmonary disease (COPD) or other lung disease * Central nervous system disorders * Liver disease * Glaucoma * Preoperative or chronic opioid use * Diagnosis of fibromyalgia * Preoperative shoulder pain * Conversion to laparotomy * Intraoperative bladder or bowel injury * Inability to understand or utilize visual analog scale * Undergoing concurrent reconstructive procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal/pelvic pain and right subscapular pain rated on a VAS at five perioperative points | From before procedure to 24 hours post procedure | Baseline score at preoperative time point and 4 time points post operative |
| Total analgesic use postoperatively | from end of procedure to 24 hours post procedure | analgesic use in the post operative period will be calculated in morphine equivalents |
Countries
United States
Contacts
CONTACTPatti Parker, BSN
CONTACTPaul Miller, MD
STUDY_CHAIRPaul Miller, JDMD
Prisma Health
Outcome results
None listed