RCT Superior Hypogastric Block During LH

• Sponsor: Jon I. Einarsson (Other)
• Overall Status: Completed
• CT.gov ID: NCT03283436
• Collaborator: University of North Carolina (Other), George Washington University (Other)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Actual Duration (Months): 13.1
• Patients Per Site: 50
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hysterectomy	Drug: Bupivacaine Hydrochloride 0.25% Injection Solution	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy: a Randomized Controlled Trial.
• Actual Study Start Date: Jan 18, 2018
• Actual Primary Completion Date: Feb 21, 2019
• Actual Study Completion Date: Feb 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Bupivacaine Hydrochloride 0.25% Injection Solution; 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg); Other Names: Bupivacaine
No Intervention: No block Patients in the control arm will undergo the hysterectomy with no intervention.

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain Scores [Admission to recovery unit and every hour after for 2 hours]

   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.

Secondary Outcome Measures

1. Postoperative Opioid Use [Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery]

   Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.

2. Postoperative Pain Scores [Discharge to 1 week after surgery, assessed up to 1 week after surgery]

   Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
2	Faulkner Hospital	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

• Jon I. Einarsson
• University of North Carolina
• George Washington University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 13, 2018

More Information

Publications

None provided.

• Responsible Party: Jon I. Einarsson, Division Chair, Minimally Invasive Gynecology, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03283436
• Other Study ID Numbers: 2017P001804
• First Posted: Sep 14, 2017
• Last Update Posted: Oct 27, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Jon I. Einarsson, Division Chair, Minimally Invasive Gynecology, Brigham and Women's Hospital: Laparoscopy; Superior hypogastric plexus block
• Additional relevant MeSH terms: Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Superior Hypogastric Plexus Block	No Block
Arm/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. Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)	Patients in the control arm will undergo the hysterectomy with no intervention.
Period Title: Overall Study
STARTED	50	50
COMPLETED	44	50
NOT COMPLETED	6	0

Baseline Characteristics

Arm/Group Title	Superior Hypogastric Plexus Block	No Block	Total
Arm/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. Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)	Patients in the control arm will undergo the hysterectomy with no intervention.	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	44	45	45
Sex: Female, Male (Count of Participants)
Female	50 100%	50 100%	100 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White/Caucasian	35 70%	29 58%	64 64%
Black/African American	8 16%	14 28%	22 22%
Hispanic	2 4%	2 4%	4 4%
Asian	2 4%	2 4%	4 4%
Other	3 6%	3 6%	6 6%
Region of Enrollment (Count of Participants)
United States	50 100%	50 100%	100 100%
Body Mass Index (BMI) (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	28.7	30.5	29.5
Gravidity (Pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Pregnancies]	2	2	2
Parity (Pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Pregnancies]	2	2	2
Indication for Surgery (Count of Participants)
Fibroids	25 50%	20 40%	45 45%
Abnormal Uterine Bleeding	10 20%	13 26%	23 23%
Pelvic pain	12 24%	16 32%	28 28%
Other	3 6%	1 2%	4 4%

Outcome Measures

1. Primary Outcome

Title	Postoperative Pain Scores
Description	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.
Time Frame	Admission to recovery unit and every hour after for 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Superior Hypogastric Plexus Block	No Block
Arm/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. Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)	Patients in the control arm will undergo the hysterectomy with no intervention.
Measure Participants	50	50
Mean (Inter-Quartile Range) [score on a scale]	3.9	4.7

2. Secondary Outcome

Title	Postoperative Opioid Use
Description	Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
Time Frame	Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Superior Hypogastric Plexus Block	No Block
Arm/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. Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)	Patients in the control arm will undergo the hysterectomy with no intervention.
Measure Participants	50	50
postoperative day 0	5	10.2
postoperative day 1	2.5	5
postoperative day 2	0	2.5
postoperative day 3	0	3.5
postoperative day 4	0	0
postoperative day 5	0	0
postoperative day 6	0	0

3. Secondary Outcome

Title	Postoperative Pain Scores
Description	Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.
Time Frame	Discharge to 1 week after surgery, assessed up to 1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Superior Hypogastric Plexus Block	No Block
Arm/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. Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)	Patients in the control arm will undergo the hysterectomy with no intervention.
Measure Participants	50	50
postoperative day 0	5	6
postoperative day 1	6.3	5.6
postoperative day 2	5.5	5
postoperative day 3	4.1	4
postoperative day 4	4	4
postoperative day 5	3	3.5
postoperative day 6	2.8	2.8

Adverse Events

Time Frame	one month after surgery for each study participant
Arm/Group Title	Superior Hypogastric Plexus Block		No Block
Arm/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. Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)		Patients in the control arm will undergo the hysterectomy with no intervention.
All Cause Mortality
	Superior Hypogastric Plexus Block		No Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Serious Adverse Events
	Superior Hypogastric Plexus Block		No Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Superior Hypogastric Plexus Block		No Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.