Post-operative Pain Relief in Laparoscopic Cholecystectomy

Post-operative Pain Relief in Laparoscopic Cholecystectomy Using a Combination of Intraperitoneal Bupivacaine Morphine, Bupivacaine Fentanyl and Bupivacaine Ketamine: A Comparative Study

compare the analgesic efficacy of the combination of bupivacaine and morphine, bupivacaine and fentanyl and bupivacaine and ketamine in alleviating post operative pain following laparoscopic cholecystectomy.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: bupivacaine; Drug: morphine; Drug: fentanyl; Drug: Ketamine:

Detailed Description

Laparoscopic cholecystectomy is comparatively advantageous over open cholecystectomy in pain management with shorter duration of hospital stays. Pain management is medically pertinent for optimal care in surgical patients. Although development and advancement in understanding of the patho-physiology of pain, analgesics, pharmacology and the development of better effective techniques for post-operative pain control, patients still continue to experience considerable discomfort.

Laparotomy results in parietal pain, whereas laparoscopy has a visceral component, a somatic component and shoulder pain secondary to diaphragmatic irritation because of CO2 pneumo-peritoneum. Postoperative pain associated with laparoscopic cholecystectomy, although less severe and of shorter duration than that after open cholecystectomy, is still a source of marked discomfort and surgical stress. The degree of the pain after laparoscopic procedures has multifactorial influence including the volume of residual gas, type of gas used for pneumo-peritoneum, pressure created by the pneumo-peritoneum and insufflated gas temperature.

Local anesthetic infiltration of the incision sites decreases postoperative opiate requirement and improves subjective pain scores but does eliminate the pain.

Earlier scientists have also reported several beneficial effects of the intra-peritoneal application of bupivacaine with morphine on postoperative pain management after laparoscopic cholecystectomy.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) classification I and II
• scheduled for elective laparoscopic cholecystectomy
• under a standardized general anesthesia technique.

Exclusion Criteria:

• uncooperative, unwilling,
• history of anaphylaxis to local anesthetics and/or opioids and the drugs to be used,
• history of drug abuse,
• anmorbidly obese patients,
• ASA classification III, IV, V
• d patients having any other significant co-morbidities
• any other with psychiatric disease
• pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A (placebo): instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion	Drug: bupivacaine; Bupivacaine 25 ml (0.25%)
Active Comparator: Group B; Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)	Drug: bupivacaine; Bupivacaine 25 ml (0.25%); Drug: morphine; Morphine (3.0 mg)
Active Comparator: Group C; Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)	Drug: bupivacaine; Bupivacaine 25 ml (0.25%); Drug: fentanyl; fentanyl (30.0 Mc)
Active Comparator: Group D; Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).	Drug: bupivacaine; Bupivacaine 25 ml (0.25%); Drug: Ketamine: ketamine (0.5 mg/kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	All subjects will be familiar with the visual analogue scale of pain (VAS) score preoperatively and will be instructed in detail on its use as a tool for measuring postoperative pain The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme . A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) .	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Khurana S, Garg K, Grewal A, Kaul TK, Bose A. A comparative study on postoperative pain relief in laparoscopic cholecystectomy: Intraperitoneal bupivacaine versus combination of bupivacaine and buprenorphine. Anesth Essays Res. 2016 Jan-Apr;10(1):23-8. doi: 10.4103/0259-1162.164731.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Ketamine; Fentanyl; Bupivacaine; Morphine
• Other Study ID Numbers: post-oprative pain relief

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No