Clinical trial NCT03283436: RCT Superior Hypogastric Block During LH
Official title: Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hysterectomy
Keywords: Laparoscopy
Superior hypogastric plexus block
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: George Washington University
First posted: 2017-09-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Over age 18
* English Speaking
* Able to provide informed consent
* Undergoing laparoscopic hysterectomy for benign indications

Exclusion Criteria:

* Planned laparotomy incision
* Planned procedure that requires dissection of the presacral space
* Allergy to block medication (s)
* Known or suspected malignancy
* Non-English speaker

Primary outcomes:
measure: Postoperative Pain Scores
timeFrame: Admission to recovery unit and every hour after for 2 hours
Secondary outcomes:
measure: Postoperative Opioid Use
timeFrame: Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery
measure: Postoperative Pain Scores
timeFrame: Discharge to 1 week after surgery, assessed up to 1 week after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Faulkner Hospital
state: Massachusetts
Study officials:
References:
citation: Clark NV, Moore K, Maghsoudlou P, North A, Ajao MO, Einarsson JI, Louie M, Schiff L, Moawad G, Cohen SL, Carey ET. Superior Hypogastric Plexus Block to Reduce Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2021 Apr 1;137(4):648-656. doi: 10.1097/AOG.0000000000004329.