MedDataX Logo

RCT Superior Hypogastric Block During LH

NCT ID: NCT03283436

Last Updated: 2020-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2019-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hysterectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will be blinded to the treatment arm; however, the surgeon will know if a patient has been randomized to receive the block during the hysterectomy.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Superior hypogastric plexus block

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.

Group Type EXPERIMENTAL

Bupivacaine Hydrochloride 0.25% Injection Solution

Intervention Type DRUG

10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)

No block

Patients in the control arm will undergo the hysterectomy with no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine Hydrochloride 0.25% Injection Solution

10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bupivacaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of North Carolina

OTHER

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role collaborator

Jon I. Einarsson

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jon I. Einarsson

Division Chair, Minimally Invasive Gynecology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Faulkner Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33706344 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017P001804

Identifier Type: -

Identifier Source: org_study_id