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Pain, Postoperative | The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

Pain, Postoperative research study

What is the primary objective of this study?

The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain quality and whether or not gabapentin prevents the development of chronic pain conditions following thoracotomy. The main hypothesis is that gabapentin reduces the proportion of patients who develop a persistent pain condition following thoracotomy from 50% to 20%. Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point numerical rating scale, usage of epidural infusions of local and/or opioid analgesics, morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related side-effects. In addition gabapentin is expected to improve postoperative recovery by means of postoperative lung function, walking ability, health related quality of life and patient satisfaction

Who is eligible to participate?

Inclusion Criteria: - Elective lung resection via thoracotomy - Age > 18 and < 80 years Exclusion Criteria: - Inability to answer the detailed questionnaires on pain and quality of life - Psychiatric disease (ICD-10) - Severe renal impairment (se-creatinin > 110 mmol/l) - Known allergy to gabapentin, morphine, bupivacaine and / or ibuprofen - Standard use of opioid analgesics - Treatment with anticonvulsants or tricyclic antidepressants - Use of antacids 24 hours before the intake of study medication - Contraindicated placement of a thoracic epidural catheter - Previous ipsilateral thoracotomy - Presence of a chronic pain syndrome - Acute pancreatitis - A history of past or current alcohol and / or illegal substance abuse. - A history of gastric or duodenal ulcer - Gastrointestinal obstruction - Pregnancy - Participation in another intervention study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain, Postoperative

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:GabapentinPreoperatively (2 hours before surgery): 4 gabapentin capsules each containing 300 mg gabapentin (total gabapentin dose 1200 mg) Postoperative day 1: gabapentin 300 mg x 2 (total gabapentin dose 600 mg) Postoperative day 2: gabapentin 300 mg x 3 (total gabapentin dose 900 mg) Postoperative day 3: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) Postoperative day 4: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) Postoperative day 5: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)

Drug:PlaceboPreoperatively (2 hours before surgery): 4 placebo capsules Postoperative day 1: 1 placebo capsule x 2 Postoperative day 2: 1 placebo capsule x 3 Postoperative day 3: 1 placebo capsule x 4 Postoperative day 4: 1 placebo capsule x 4 Postoperative day 5: 1 placebo capsule x 4

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

GabapentinGabapentin group

PlaceboPlacebo group

Study Status

Completed

Start Date: May 2011

Completed Date: November 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Persistent post surgical pain

Secondary Outcome: Consumption of opioid analgesics

Study sponsors, principal investigator, and references

Principal Investigator: Hans K Pilegaard, MD, Chief Surgeon

Lead Sponsor: University of Aarhus

Collaborator: Aarhus University Hospital Skejby

More information:https://clinicaltrials.gov/show/NCT01116583

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