RCT Superior Hypogastric Block During LH

Jon I. Einarsson

Status and phase: Completed; Phase 4

Conditions: Hysterectomy

Treatments: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03283436

2017P001804

Details and patient eligibility

About

The goal of this study is to assess the efficacy of a superior hypogastric plexus block (SHPB) for pain relief following a laparoscopic hysterectomy.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Superior hypogastric plexus block

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine Hydrochloride 0.25% Injection Solution

No block

No Intervention group

Description:

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