Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy

Comparative Effects of Single Dose Preemptive Gabapentin or Amitriptyline on Postoperative Pain and Opioid Consumption in Single Level Lumbar Laminectomy and Diskectomy: A Double Blind RCT With Placebo Control

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01014520

Enrollment

120

Registered

2009-11-17

Start date

2009-05-31

Completion date

2010-03-31

Last updated

2009-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herniated Disc, Intervertebral Disc Displacement

Keywords

Lumbar, Diskectomy, Laminectomy

Brief summary

The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.

Detailed description

Pain suppression plays a decisive role in patients' satisfaction following lumbar diskectomies, as the psychological component of the pain is a major cause of treatment failure. Controversy exists whether preemptive prescription of gabapentin, as a known contributor to reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of amitriptyline and gabapentin in this group of neurosurgical patients.

Interventions

DRUGGabapentin , Amitriptyline

Capsule, 300 mg, oral, single dose 2 hours before surgery Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Signed Informed Consent * Age:18 to 60 * Weight: 60 to 80 Kg * ASA Class: I,II * Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation * Single level lumbar disk herniation unresponsive to medical treatment

Exclusion criteria

* Previous consumption of Gabapentin or Amitriptyline * Known allergy to investigated drugs * Reluctant to sign informed consent * Previous history of intolerance to narcotics * Simultaneous lumbar diskectomy and a fusion technique * Known renal failure * Pregnancy * Contraindications to Amitriptyline or Gabapentin prescription * Unable to use PCA * Habitual use of alcohol or opium * History of analgesic consumption during the last 24hours

Design outcomes

Primary

Measure	Time frame
30% reduction in opium consumption in either study arms compared to the placebo group	Within the first 24 hours after surgery

Secondary

Measure	Time frame
30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group	Within the first 24 hours after surgery

Countries

Iran

Contacts

Primary ContactDawood Aghamohammadi, MD

daghamohamadi@yahoo.com+98 411 3340830

Backup ContactPayman Vahedi, MD

payman.vahedi@gmail.com+98 411 3340830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026