Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02359110
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Duration (Months): 19.1
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Gabapentin; Other: Placebo	Phase 4

Detailed Description

The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. We hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.

We plan to conduct a prospective randomized trial to assess the effect of a single immediate pre-operative dose of gabapentin 300mg on immediate post-operative pain in patients undergoing laparoscopy for gynecologic indications. This concept has been studied in patients undergoing abdominal hysterectomy. We aim to study the effect on patients undergoing laparoscopy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy: A Prospective Double-blinded, Placebo Controlled Randomized Study
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drug 1 Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Drug: Gabapentin; Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.; Other Names: Neurontin 78309289
Placebo Comparator: Drug 2 Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.	Other: Placebo; Patient will receive placebo tab less than 1 hour before surgery

Outcome Measures

Primary Outcome Measures

1. NRS (Numerical Rating Scale) [2-8 hours]

   The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.

Secondary Outcome Measures

1. VAS (Visual Analog Scale) [2 -6 hours]

   The VAS is scored using a horizontal line 100mm in length. The scale is anchored by "no pain" (score of 0) and "worst pain" (score of 100).

2. Total Morphine Consumption [12 hours post-operatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. The patient must be female and planning to have a laparoscopic or robotic assisted procedure for benign gynecologic indications.

2. Patients must be treated in the department of Obstetrics and Gynecology in the division of Minimally Invasive Gynecologic Surgery.

3. The patient must be in the age range of 18-80 years, in general good health and able to comply with study procedures.

Exclusion Criteria:

1. Male patients will be excluded from this study.

2. Patients under 18 years old will be excluded from this study.

3. Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude pregnancy.

4. Patients having abdominal, vaginal or hysteroscopic procedures

5. Allergy to gabapentin

6. Chronic use of gabapentin (greater than 6 months)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Alayed N, Alghanaim N, Tan X, Tulandi T. Preemptive use of gabapentin in abdominal hysterectomy: a systematic review and meta-analysis. Obstet Gynecol. 2014 Jun;123(6):1221-1229. doi: 10.1097/AOG.0000000000000289. Review.
• Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. Epub 2006 Dec 16.
• Clarke H, Bonin RP, Orser BA, Englesakis M, Wijeysundera DN, Katz J. The prevention of chronic postsurgical pain using gabapentin and pregabalin: a combined systematic review and meta-analysis. Anesth Analg. 2012 Aug;115(2):428-42. doi: 10.1213/ANE.0b013e318249d36e. Epub 2012 Mar 13. Review.
• Hartrick CT, Kovan JP, Shapiro S. The numeric rating scale for clinical pain measurement: a ratio measure? Pain Pract. 2003 Dec;3(4):310-6.
• Manwaring JM, Readman E, Maher PJ. The effect of heated humidified carbon dioxide on postoperative pain, core temperature, and recovery times in patients having laparoscopic surgery: a randomized controlled trial. J Minim Invasive Gynecol. 2008 Mar-Apr;15(2):161-5. doi: 10.1016/j.jmig.2007.09.007.
• Nutthachote P, Sirayapiwat P, Wisawasukmongchol W, Charuluxananan S. A randomized, double-blind, placebo-controlled trial of oral pregabalin for relief of shoulder pain after laparoscopic gynecologic surgery. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):669-73. doi: 10.1016/j.jmig.2014.01.018. Epub 2014 Jan 25.
• Ott DE, Reich H, Love B, McCorvey R, Toledo A, Liu CY, Syed R, Kumar K. Reduction of laparoscopic-induced hypothermia, postoperative pain and recovery room length of stay by pre-conditioning gas with the Insuflow device: a prospective randomized controlled multi-center study. JSLS. 1998 Oct-Dec;2(4):321-9.
• Sills GJ. The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol. 2006 Feb;6(1):108-13. Epub 2005 Dec 22. Review.
• Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.

• Responsible Party: Timothy A Deimling, Principal Investigator; Minimally Invasive Gyn Surgery Fellow, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02359110
• Other Study ID Numbers: 1183
• First Posted: Feb 9, 2015
• Last Update Posted: Mar 12, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Timothy A Deimling, Principal Investigator; Minimally Invasive Gyn Surgery Fellow, Milton S. Hershey Medical Center: laparoscopy; postoperative pain; gynecology; gabapentin
• Additional relevant MeSH terms: Pain, Postoperative; Gabapentin

Study Results

Participant Flow

Recruitment Details	A total of 125 patients consented to the study, but 13 did not undergo surgery or rescheduled.
Pre-assignment Detail	A total of 112 patients were enrolled, but 3 did not receive study drug.

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Period Title: Overall Study
STARTED	55	54
COMPLETED	55	54
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Gabapentin	Placebo	Total
Arm/Group Description	Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.	Total of all reporting groups
Overall Participants	55	54	109
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.4 (9.8)	39.5 (9.4)	39.9 (9.5)
Sex: Female, Male (Count of Participants)
Female	55 100%	54 100%	109 100%
Male	0 0%	0 0%	0 0%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	29.5 (7.2)	30.0 (7.7)	29.8 (7.4)

Outcome Measures

1. Primary Outcome

Title	NRS (Numerical Rating Scale)
Description	The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.
Time Frame	2-8 hours

Outcome Measure Data

Analysis Population Description

Our analysis uses all available data. Some participants were not in house for the full 8 hours of collection, others did not complete NRS at the respective time point. Therefore the number at each time point differs from the overall number of participants.

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Measure Participants	55	54
Hour 2	3.5	3.4
Hour 4	5.4	5.5
Hour 6	5.3	5.8
Hour 8	5.7	5.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	Hour 2 Analysis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -1.2 to 1.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	Hour 4 Analysis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -1.6 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	Hour 6 Analysis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -2.2 to 1.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	Hour 8 Analysis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.59
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -1.6 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	VAS (Visual Analog Scale)
Description	The VAS is scored using a horizontal line 100mm in length. The scale is anchored by "no pain" (score of 0) and "worst pain" (score of 100).
Time Frame	2 -6 hours

Outcome Measure Data

Analysis Population Description

Our analysis uses all available data. Some participants were not in house for the full 6 hours of collection, others did not complete VAS at the respective time point. Therefore the number at each time point differs from the overall number of participants.

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Measure Participants	55	54
Hour 2	37.8	33.9
Hour 6	38.7	36.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	Hour 2 Analysis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.8
	Confidence Interval	(2-Sided) 95%; -8.1 to 15.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	Hour 6 Analysis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -11.9 to 15.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Total Morphine Consumption
Time Frame	12 hours post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Measure Participants	55	54
Mean (Standard Deviation) [mg]	14.3 (12.6)	14.7 (12.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Gabapentin		Placebo
Arm/Group Description	Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.		Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
All Cause Mortality
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/54 (0%)
Serious Adverse Events
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/54 (0%)
Other (Not Including Serious) Adverse Events
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/54 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.