Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery

Non-obstetric Lower Abdominal Surgery Clinical Trial

Official title:

Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434430
• Other study ID #: IndonesiaUAnes 054
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 11, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: September 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-obstetric Lower Abdominal Surgery

Intervention

Drug:
• Gabapentin
Oral Gabapentin 600 mg

Other:
• Placebo
Oral NaCl 500 mg

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (6)

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. — View Citation

Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306. — View 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. Review. — View 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- — View 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. Epub 2006 Sep 29. Review. — View 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):139-44. doi: 10.1016/S0140-6736(08)60878-8. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery	Measured by total consumption of morphine on patient controlled analgesia machine	24 hours after surgery
Primary	Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale	Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.; The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.	24 hours after surgery
Secondary	Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale	Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.; The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.	2 hours after surgery
Secondary	Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale	Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.; The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.	6 hours after surgery
Secondary	Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale	Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.; The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.	12 hours after surgery
Secondary	Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery	Measured by total consumption of morphine on patient controlled analgesia machine	2 hours after surgery
Secondary	Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery	Measured by total consumption of morphine on patient controlled analgesia machine	6 hours after surgery
Secondary	Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery	Measured by total consumption of morphine on patient controlled analgesia machine	12 hours after surgery