RCT Superior Hypogastric Block During LH
- Conditions
- Hysterectomy
- Interventions
- Registration Number
- NCT03283436
- Lead Sponsor
- Jon I. Einarsson
- Brief Summary
The goal of this study is to assess the efficacy of a superior hypogastric plexus block (SHPB) for pain relief following a laparoscopic hysterectomy.
- Detailed Description
The objective of this study is to assess the efficacy of a SHPB for pain relief following laparoscopic hysterectomy. The superior hypogastric plexus lies in the presacral space and supplies autonomic innervation to the central pelvis. This plexus is suspected to play a role in postoperative pain following a hysterectomy. The investigators hypothesize that a SHPB using the anesthetic bupivacaine will reduce patients' pain scores and opioid consumption following a laparoscopic hysterectomy. Intraoperative and immediate postoperative opioid consumption will be collected from the Medication Administration Record by the nursing staff. The nursing staff will also be asked to complete a recovery worksheet that details the Visual Analog Scale pain score and opioid administration on admission to the recovery unit and every postoperative hour until six hours or the patient is discharged. Patients will also be asked to complete a daily diary for one week following the procedure, which details their pain level and daily opioid consumption. Patients will be followed for thirty days after surgery to assess for the occurrence of any postoperative complications. Detailed patient and procedure characteristics including age, race, body mass index, parity, surgical history, surgery indication, procedure type, and surgical approach will also be collected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- Over age 18
- English Speaking
- Able to provide informed consent
- Undergoing laparoscopic hysterectomy for benign indications
- Planned laparotomy incision
- Planned procedure that requires dissection of the presacral space
- Allergy to block medication (s)
- Known or suspected malignancy
- Non-English speaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Superior hypogastric plexus block Bupivacaine Hydrochloride 0.25% Injection Solution Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
- Primary Outcome Measures
Name Time Method Postoperative Pain Scores Admission to recovery unit and every hour after for 2 hours The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.
- Secondary Outcome Measures
Name Time Method Postoperative Opioid Use Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
Postoperative Pain Scores Discharge to 1 week after surgery, assessed up to 1 week after surgery Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (2)
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Faulkner Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Women's Hospital🇺🇸Boston, Massachusetts, United States