Preemptive Analgesia Following Uterine Artery Embolization

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01555073
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 4
• Duration (Months): 24
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has been hysterectomy in post child bearing woman. However, over the last decade, the use of a minimal invasive technique called uterine artery embolization has become increasingly popular due to high patient satisfaction, cost effectiveness, and shorter recovery period. The purpose of this randomized blinded placebo controlled study is to compare pre-emptive analgesia vs non-preemptive analgesia for immediate postoperative pain control, long term pain control, and improved quality of life in woman following uterine artery embolization surgery. The study consists of four drug groups including a placebo group. The addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as leading to a better post-procedure outcome in women following uterine artery embolization.

Many investigators believe that the ischemia in the normal myometrium is the primary source of pain immediately following surgery making postoperative pain management challenging. Epidural fentanyl may offer an advantage when encountering visceral pain. In addition to being an effective analgesic for chronic pain syndromes, the use of pregabalin provides effective postoperative analgesia when it is administered pre-emptively before an operation. Preemptive analgesia involves the introduction of an analgesic regimen before the onset of noxious stimuli, with the goal of preventing sensitization of the nervous system to subsequent stimuli that could amplify pain. In human trials, pregabalin has been demonstrated to reduce pain, improve sleep, and mood disturbances in patients with post herpetic neuralgia. The use of celecoxib in combination with pregabalin has shown to provide more effective analgesia by providing antihyperalgesia. Therefore, the addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as having an effect on long term sequelae.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids; Uterine Artery Embolization	Drug: pregabalin/celecoxib; Drug: pregabalin/placebo; Drug: celecoxib/placebo; Drug: Placebo group	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pregabalin/celecoxib group pregabalin/celecoxib twice a day for 13 days.	Drug: pregabalin/celecoxib; pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.; Other Names: Celebrex Lyrica
Active Comparator: Pregabalin/placebo group pregabalin/placebo twice a day for 13 days.	Drug: pregabalin/placebo; pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.; Other Names: Lyrica
Active Comparator: Celecoxib/placebo group celecoxib/placebo twice a day for 13 days.	Drug: celecoxib/placebo; celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.; Other Names: Celebrex
Placebo Comparator: Placebo group Placebo group, two placebo tablets day of surgery and twice a day for 13 days	Drug: Placebo group; Placebo group, two placebo tablets day of surgery and twice a day for 13 days; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Post Operative Pain Control [Expected average of 12 weeks]

   To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.

Secondary Outcome Measures

1. Quality of Life [Expected average of 12 weeks]

   To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult female patients (>18 years of age) who are undergoing elective uterine artery embolization will be included in the study.

Exclusion Criteria:

• Exclusion criteria for the study are patient refusal to be included in the study, the presence of language barrier that inhibits proper communication with the patient

• Contraindications to regional anesthesia

• History of allergy to amide local anesthetics or narcotics

• Known hypersensitivity to pregabalin, creatinine clearance ≤ 60 mL/min

• The presence of a progressive neurological deficit

• The presence of chronic opioid analgesia

• The presence of a coagulopathy or infection, pregnancy

• Patients with cardiovascular disease

• Patients who take daily antiplatelet medications, patients with peptic ulcer disease

• History of psychiatric disorder or inability to follow study protocol.

• Dropout criteria include failed epidural analgesia, inability to tolerate side effects (nausea) from pregabalin, and the inability to contact during follow up.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antoun Nader, Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University
• ClinicalTrials.gov Identifier: NCT01555073
• Other Study ID Numbers: STU00004604
• First Posted: Mar 15, 2012
• Last Update Posted: Jul 28, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Leiomyoma; Celecoxib; Pregabalin

Study Results

Participant Flow

Arm/Group Title	Pregabalin/Celecoxib Group	Pregabalin/Placebo Group	Celecoxib/Placebo Group	Placebo Group
Arm/Group Description	pregabalin/celecoxib twice a day for 13 days. pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.	pregabalin/placebo twice a day for 13 days. pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.	celecoxib/placebo twice a day for 13 days. celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.	Placebo group, two placebo tablets day of surgery and twice a day for 13 days Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Period Title: Overall Study
STARTED	7	3	7	6
COMPLETED	6	1	7	1
NOT COMPLETED	1	2	0	5

Baseline Characteristics

Arm/Group Title	Pregabalin/Celecoxib Group	Pregabalin/Placebo Group	Celecoxib/Placebo Group	Placebo Group	Total
Arm/Group Description	pregabalin/celecoxib twice a day for 13 days. pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.	pregabalin/placebo twice a day for 13 days. pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.	celecoxib/placebo twice a day for 13 days. celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.	Placebo group, two placebo tablets day of surgery and twice a day for 13 days Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days	Total of all reporting groups
Overall Participants	7	3	7	6	23
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	3 100%	7 100%	6 100%	23 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 100%	3 100%	7 100%	6 100%	23 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Post Operative Pain Control
Description	To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.
Time Frame	Expected average of 12 weeks

Outcome Measure Data

Analysis Population Description

Early termination due to lost of follow-up for primary outcome at 3 months

Arm/Group Title	Pregabalin/Celecoxib Group	Pregabalin/Placebo Group	Celecoxib/Placebo Group	Placebo Group
Arm/Group Description	pregabalin/celecoxib twice a day for 13 days. pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.	pregabalin/placebo twice a day for 13 days. pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.	celecoxib/placebo twice a day for 13 days. celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.	Placebo group, two placebo tablets day of surgery and twice a day for 13 days Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Measure Participants	0	0	0	0

2. Secondary Outcome

Title	Quality of Life
Description	To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.
Time Frame	Expected average of 12 weeks

Outcome Measure Data

Analysis Population Description

Early termination due to lost of follow-up for primary outcome at 3 months

Arm/Group Title	Pregabalin/Celecoxib Group	Pregabalin/Placebo Group	Celecoxib/Placebo Group	Placebo Group
Arm/Group Description	pregabalin/celecoxib twice a day for 13 days. pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.	pregabalin/placebo twice a day for 13 days. pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.	celecoxib/placebo twice a day for 13 days. celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.	Placebo group, two placebo tablets day of surgery and twice a day for 13 days Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Measure Participants	0	0	0	0

Adverse Events

Arm/Group Title	Pregabalin/Celecoxib Group		Pregabalin/Placebo Group		Celecoxib/Placebo Group		Placebo Group
Arm/Group Description	pregabalin/celecoxib twice a day for 13 days. pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.		pregabalin/placebo twice a day for 13 days. pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.		celecoxib/placebo twice a day for 13 days. celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.		Placebo group, two placebo tablets day of surgery and twice a day for 13 days Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
All Cause Mortality
	Pregabalin/Celecoxib Group		Pregabalin/Placebo Group		Celecoxib/Placebo Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Pregabalin/Celecoxib Group		Pregabalin/Placebo Group		Celecoxib/Placebo Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)		0/7 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Pregabalin/Celecoxib Group		Pregabalin/Placebo Group		Celecoxib/Placebo Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)		0/7 (0%)		0/6 (0%)

Limitations/Caveats

Early termination due to lost of follow-up for primary outcome at 3 months

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.