Trials / Completed
CompletedNCT03283436
RCT Superior Hypogastric Block During LH
Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy: a Randomized Controlled Trial.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Jon I. Einarsson · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bupivacaine Hydrochloride 0.25% Injection Solution | 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg) |
Timeline
- Start date
- 2018-01-18
- Primary completion
- 2019-02-21
- Completion
- 2019-02-21
- First posted
- 2017-09-14
- Last updated
- 2020-10-27
- Results posted
- 2020-09-16
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03283436. Inclusion in this directory is not an endorsement.