Post-operative Pain Relief in Laparoscopic Cholecystectomy

• ClinicalTrials.gov Identifier: NCT03355716
• Recruitment Status: Unknown
• First Posted: November 28, 2017
• Last Update Posted: November 28, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohammed Ahmed Mahmoud, Assiut University

Tracking Information

• First Submitted Date: November 21, 2017
• First Posted Date: November 28, 2017
• Last Update Posted Date: November 28, 2017
• Estimated Study Start Date: January 2018
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 27, 2017)

post operative pain [ Time Frame: 24 hours ]

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) .

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Post-operative Pain Relief in Laparoscopic Cholecystectomy
• Official Title: Post-operative Pain Relief in Laparoscopic Cholecystectomy Using a Combination of Intraperitoneal Bupivacaine Morphine, Bupivacaine Fentanyl and Bupivacaine Ketamine: A Comparative Study
• Brief Summary: 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.

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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

At the end of the procedure, all the subjects will be randomly allocated to groups using computer-generated random numbers. Each group of 30 subjects, that is,

Group A (placebo):

instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion;

Group B :

Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)

Group C :

Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)

Group D :

Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

• Condition: Postoperative Pain

Intervention

• Drug: bupivacaine
  Bupivacaine 25 ml (0.25%)
• Drug: morphine
  Morphine (3.0 mg)
• Drug: fentanyl
  fentanyl (30.0 Mc)
• Drug: Ketamine:
  ketamine (0.5 mg/kg).

Study Arms

• Placebo Comparator: Group A (placebo):
  instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion
  Intervention: Drug: bupivacaine
• Active Comparator: Group B
  Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)
  Interventions:

  • Drug: bupivacaine
  • Drug: morphine
• Active Comparator: Group C
  Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)
  Interventions:

  • Drug: bupivacaine
  • Drug: fentanyl
• Active Comparator: Group D
  Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).
  Interventions:

  • Drug: bupivacaine
  • Drug: Ketamine:

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 27, 2017): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2019
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03355716
• Other Study ID Numbers: post-oprative pain relief
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Responsible Party: Mohammed Ahmed Mahmoud, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: November 2017