Clinical trial NCT04434430: Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery
Official title: Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-obstetric Lower Abdominal Surgery
Keywords: preemptive analgesia
gabapentin
morphine
lower abdominal surgery
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery

Detailed description: Seventy-two subjects were given informed consent before enrolling the study and randomized into two groups; gabapentin and placebo. Two hours before the incision, patients were given preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were extubated until fully conscious. Patients will be transported to recovery room postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement, interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine requirement, mean visual analogue scale, and time interval after surgery to the first administration of morphine will be assessed in this study.

Eligibility criteria: Inclusion criteria:

* Male or female
* Age: 18-65 years old
* Weigh in range around 20% of the ideal body weight
* Physical status ASA I-II
* Scheduled for elective non-obstetric lower abdominal surgery with general anesthesia
* Duration of surgery less than 4 hours
* Patients who agreed to participate in this study and sign informed consent

Exclusion criteria:

* Patients who have history of allergy or hypersensitivity to gabapentin, paracetamol, morphine, or the other opioids
* Patients who consumed analgesia and NSAID less than 12 hours before surgery
* Patients who experienced physical trauma less than 4 days before surgery
* Patients who have contraindications to gabapentin, morphine, and paracetamol
* Patients who were treated with neuraxial block or peripheral nerve block before and during surgery
* Patients who have history of diabetes, severe live or renal disease
* Patients who were treated with antihypertension, sedatives, hypnotics, antidepressants, and the other drugs that have effects on nervous system
* Patients who have psychiatric disorders
* Patients who consumed gabapentin before perioperative period
* Pregnant or breastfeeding patients

Primary outcomes:
measure: Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery
timeFrame: 24 hours after surgery
measure: Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
timeFrame: 2 hours after surgery
measure: Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
timeFrame: 6 hours after surgery
measure: Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
timeFrame: 12 hours after surgery
measure: Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery
timeFrame: 2 hours after surgery
measure: Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery
timeFrame: 6 hours after surgery
measure: Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery
timeFrame: 12 hours after surgery
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
References:
citation: Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
citation: Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
citation: Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
citation: Shavit Y, Fridel K, Beilin B. Postoperative pain management and proinflammatory cytokines: animal and human studies. J Neuroimmune Pharmacol. 2006 Dec;1(4):443-51. doi: 10.1007/s11481-006-9043-1. Epub 2006 Sep 29.
citation: Beilin B, Shavit Y, Trabekin E, Mordashev B, Mayburd E, Zeidel A, Bessler H. The effects of postoperative pain management on immune response to surgery. Anesth Analg. 2003 Sep;97(3):822-827. doi: 10.1213/01.ANE.0000078586.82810.3B.
citation: Lee BH, Park JO, Suk KS, Kim TH, Lee HM, Park MS, Lee SH, Park S, Lee JY, Ko SK, Moon SH. Pre-emptive and multi-modal perioperative pain management may improve quality of life in patients undergoing spinal surgery. Pain Physician. 2013 May-Jun;16(3):E217-26.