NCT03283436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 16, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

September 12, 2017

Results QC Date

August 12, 2020

Last Update Submit

October 4, 2020

Conditions

Hysterectomy

Keywords

LaparoscopySuperior hypogastric plexus block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Scores

    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.

    Admission to recovery unit and every hour after for 2 hours

Secondary Outcomes (2)

  • Postoperative Opioid Use

    Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery

  • Postoperative Pain Scores

    Discharge to 1 week after surgery, assessed up to 1 week after surgery

Study Arms (2)

Superior hypogastric plexus block

EXPERIMENTAL

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.

Drug: Bupivacaine Hydrochloride 0.25% Injection Solution

No block

NO INTERVENTION

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

Interventions

Bupivacaine Hydrochloride 0.25% Injection SolutionDRUG

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

Also known as: Bupivacaine
Superior hypogastric plexus block

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • 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.

    PMID: 33706344DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Jon Einarsson
Organization
Brigham and Women's Hospital
jeinarsson@partners.org
617-525-8582

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division Chair, Minimally Invasive Gynecology

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

January 18, 2018

Primary Completion

February 21, 2019

Study Completion

February 21, 2019

Last Updated

October 27, 2020

Results First Posted

September 16, 2020

Record last verified: 2020-10

Locations

US(2)