Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

NCT05172570 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 10069
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Gabapentin is a nerve medication that treats pain. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. Our hypothesis is that higher doses of gabapentin will correlate with decreased pain at the incision and chest tube sites and decreased opioid consumption.

Conditions

Thoracotomy; Pain, Postoperative

Keywords

acute pain; neuropathic pain

Outcome Measures

Primary Outcomes (5)

• The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

  The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.

  1 hour after surgery

• The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

  The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.

  24 hour after surgery

• The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

  The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.

  48 hour after surgery

• The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

  The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.

  72 hour after surgery

• The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

  The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.

  96 hour after surgery

Secondary Outcomes (26)

• Opioid Usage

  1 hour after surgery.

• Opioid Usage

  24 hour after surgery.

• Opioid Usage

  48 hour after surgery.

• Opioid Usage

  72 hour after surgery.

• Opioid Usage

  96 hour after surgery.

Study Arms (3)

No Gabapentin

NO INTERVENTION

Patients will not receive any gabapentin postoperatively after open thoracotomy

300 mg Gabapentin 3X per day

ACTIVE COMPARATOR

Patients will receive 300mg gabapentin 3x a day after open thoracotomy

Drug: Gabapentin

300 mg Gabapentin once per day at night

ACTIVE COMPARATOR

Patients will receive 300mg gabapentin once a day at night after open thoracotomy

Drug: Gabapentin

Interventions

Gabapentin DRUG

Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.

Also known as: neurontin

300 mg Gabapentin 3X per day; 300 mg Gabapentin once per day at night

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pt undergoing open thoracotomy at Indiana University Hospital
• ASA 1,2,3 or 4
• Age 18 or older, male or female

You may not qualify if:

• History of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs
• Patient on home dose of gabapentin or pregabalin
• Patient staying intubated after surgery
• Patient above 70yo
• Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
• Known allergy or other contraindications to the study medications, which include gabapentin
• Patient unable to receive post-op epidural
• BMI above 40
• Creatinine clearance less than 30

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (14)

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• Rogers LJ, Bleetman D, Messenger DE, Joshi NA, Wood L, Rasburn NJ, Batchelor TJP. The impact of enhanced recovery after surgery (ERAS) protocol compliance on morbidity from resection for primary lung cancer. J Thorac Cardiovasc Surg. 2018 Apr;155(4):1843-1852. doi: 10.1016/j.jtcvs.2017.10.151. Epub 2017 Dec 19.

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MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Neuralgia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

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

Results Point of Contact

• Title: Randomized prospective study comparing variable Gabapentin dosages for postoperative analgesia follo
• Organization: Indiana Univeristy School of Medicine

yyeap@iupui.edu

317-274-0275

Study Officials

• Yar Yeap, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: December 29, 2021
• Study Start: April 6, 2021
• Primary Completion: February 25, 2022
• Study Completion: March 2, 2022
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)