Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures

NCT02957097 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2016p001548
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of pre-operative administration of gabapentin 900 mg in management of acute post-operative pain in patients undergoing oral and maxillofacial surgical procedures.

Conditions

Pain, Postoperative; Acute Pain; Facial Pain

Keywords

Gabapentin; acute pain

Outcome Measures

Primary Outcomes (8)

• Intensity of pain

  Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  6 hours postoperatively

• total opioid consumption

  Consumption of opioid medication postoperatively

  24 hours

• time to first rescue analgesic

  post-operatively (up to 6 hours)

• incidence of adverse effects

  post-operatively (up to 24 hours)

• Intensity of pain

  Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  12 hours postoperatively

• Intensity of pain

  Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  24 hours postoperatively

• Intensity of pain

  Pain score of participants on a likert type pain scale (0-10), where 0 is indicative of no pain, and 10 indicates worst pain imaginable.

  72 hours postoperatively.

• total opioid consumption

  Consumption of opioid medication postoperatively.

  72 hours post-operatively

Secondary Outcomes (3)

• incidence of pain

  1 month

• intensity of pain on a numeric rating scale (0-10)

  1 month

• length of post-operative hospital-stay

  postoperatively in terms of days (up to 1 week)

Study Arms (2)

Medication - Gabapentin

EXPERIMENTAL

Participants of this group will be administered either Gabapentin 900 milligram PO 2-3 hours prior to the surgical procedure.

Drug: Gabapentin

Medication - Placebo

PLACEBO COMPARATOR

Participants of this group will be administered either Placebo PO 2-3 hours prior to the surgical procedure.

Drug: Placebo

Interventions

Gabapentin DRUG

Medication used for management of neuropathic pain conditions

Also known as: Neurontin, Gralise, Horizant

Medication - Gabapentin

Placebo DRUG

Placebo medication. It looks exactly same as the Gabapentin medication in same size, shape, and color.

Medication - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants, of any race, between ages of 18 - 65 years.
• Participants undergoing unilateral or bilateral Lefort osteotomy, unilateral or bilateral mandibular inverted-L or sagittal split osteotomy with or without genioplasty, temporomandibular joint arthroplasty with or without total joint replacement prosthesis.

You may not qualify if:

• Participants who are pregnant.
• Participants allergic to gabapentin.
• Participants with a history of alcohol, or drug abuse.
• Participants who are unwilling to participate, or are non-compliant to the guidelines of the investigation.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (12)

• Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.

  PMID: 3461421 BACKGROUND

• 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.

  PMID: 24807337 BACKGROUND

• Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.

  PMID: 17513656 BACKGROUND

• Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.

  PMID: 8346839 BACKGROUND

• Bell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. doi: 10.1111/j.1399-6576.2005.00814.x.

  PMID: 16223384 BACKGROUND

• Dauri M, Faria S, Gatti A, Celidonio L, Carpenedo R, Sabato AF. Gabapentin and pregabalin for the acute post-operative pain management. A systematic-narrative review of the recent clinical evidences. Curr Drug Targets. 2009 Aug;10(8):716-33. doi: 10.2174/138945009788982513.

  PMID: 19702520 BACKGROUND

• Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60. doi: 10.1097/00000542-200506000-00027.

  PMID: 15915040 BACKGROUND

• Pandey CK, Navkar DV, Giri PJ, Raza M, Behari S, Singh RB, Singh U, Singh PK. Evaluation of the optimal preemptive dose of gabapentin for postoperative pain relief after lumbar diskectomy: a randomized, double-blind, placebo-controlled study. J Neurosurg Anesthesiol. 2005 Apr;17(2):65-8. doi: 10.1097/01.ana.0000151407.62650.51.

  PMID: 15840990 BACKGROUND

• Remy C, Marret E, Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major surgery: meta-analysis of randomized controlled trials. Br J Anaesth. 2005 Apr;94(4):505-13. doi: 10.1093/bja/aei085. Epub 2005 Jan 28.

  PMID: 15681586 BACKGROUND

• Gilron I. Is gabapentin a "Broad-spectrum" analgesic? Anesthesiology. 2002 Sep;97(3):537-9. doi: 10.1097/00000542-200209000-00004. No abstract available.

  PMID: 12218517 BACKGROUND

• Rose MA, Kam PC. Gabapentin: pharmacology and its use in pain management. Anaesthesia. 2002 May;57(5):451-62. doi: 10.1046/j.0003-2409.2001.02399.x.

  PMID: 11966555 BACKGROUND

• Peng PW, Wijeysundera DN, Li CC. Use of gabapentin for perioperative pain control -- a meta-analysis. Pain Res Manag. 2007 Summer;12(2):85-92. doi: 10.1155/2007/840572.

  PMID: 17505569 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Facial Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: November 7, 2016
• Study Start: September 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (1)