Gabapentin and Chronic Post Surgical Pain

Browse trials for

• Scoliosis 594
• Pain, Postoperative 5,093

Keywords

• Gabapentin
• Pain medication
• Chronic postsurgical pain
• Pediatric
• Idiopathic scoliosis surgery

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Study arms

• Experimental
  Gabapentin

  Gabapentin is a common neuropathic medication used in the treatment of chronic pain. Gabapentin will be given preoperative and continued for 5 days postoperatively.

  Drug: Gabapentin

• Placebo comparator
  Placebo

  Control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group.

  Other: Placebo

Interventions

• DrugGabapentin

  Gabapentin (10 mg/kg up to 600 mg) will be given 30 minutes prior to being transported to the operating room. The gabapentin will be in the standard liquid with a concentration of 250mg/5mL. Starting postoperative day 1, patients in the experimental group will receive gabapentin three times daily. Dose of gabapentin will be 100 mg for patients \<50 kg and 200 mg for patients \> 50 kg. Gabapentin will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with gabapentin for the remainder of their doses upon discharge.

  Also known as: Neurontin

• OtherPlacebo

  Placebo will be given 30 minutes prior to being transported to the operating room. Placebo will be identically appearing to gabapentin. Starting postoperative day 1, control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group. It will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with placebo for the remainder of their doses upon discharge.

Primary outcomes

1. Change in NRS for pain intensity score comparing gabapentin and placebo groups

   Patient's included in the study will rate their current pain using the numerical rating scale (NRS). With the NRS for pain intensity, the child rates their pain on a zero to 10 Likert scale, with zero being no pain and 10 being the most pain imaginable. A NRS \> 4/10 at the time of the survey will be considered positive for CPSP.

   Time frame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively

2. Change in FDI score comparing gabapentin and placebo groups

   The functional disability inventory (FDI) is a 15 question self-report inventory that assesses the impact of daily pain on activities at home, school, recreational and social domains. Items are rated on a five-point Likert Scale, ranging from 0 to 4, representing no trouble with the activity up to impossible to do the activity. The scores are tabulated, classifying the patient's function as no to minimal disability (0-12), moderate disability (12-29) or severe disability (30-60).

   Time frame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively

Secondary outcomes

1. Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo

   Opioid consumption will be tabulated from the postoperative care unit (PACU), across nursing shifts and cumulative amounts per day. IV morphine will be converted to oral morphine equivalents using a 3:1 ratio or IV hydromorphone will be converted to IV morphine using a 5:1 ratio. Oxycodone will be converted to oral morphine equivalents using a 1:1.5 ratio. All cumulative opioids will be reported as oral morphine equivalents.

   Time frame: Postoperative period up to 1 month

2. Time to ambulation in patients receiving gabapentin versus placebo

   Time to ambulation will be recorded.

   Time frame: Postoperative period up to 1 month

3. First oral intake in patients receiving gabapentin versus placebo

   Time to first oral intake will be recorded.

   Time frame: Postoperative period up to 1 month

4. Time to discharge in each group in patients receiving gabapentin versus standard of care

   Time to discharge will be recorded.

   Time frame: Postoperative period up to 1 month

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results after de-identification (text, tables, figures and appendices) will be shared. The following related documents will be available: study protocol, statistical analysis plan, analytic code. Data will become available immediately following publication and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis. Request for proposal should be directed to Cheryl.maenpaa@emory.edu.To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.

Supporting information: Study protocol, Sap, Analytic code