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Post-operative Pain Relief in Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03355716
Recruitment Status : Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Ahmed Mahmoud, Assiut University

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: bupivacaine Drug: morphine Drug: fentanyl Drug: Ketamine: Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: Post-operative Pain Relief in Laparoscopic Cholecystectomy Using a Combination of Intraperitoneal Bupivacaine Morphine, Bupivacaine Fentanyl and Bupivacaine Ketamine: A Comparative Study
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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) .




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Ages Eligible for Study:   22 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355716


Contacts
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Contact: Mohammed Ahmed Mahmoud 0108834312 dr_m_hamouda@yahoo.com
Contact: abualauon Mohamed Abedalmohsen 01006253939

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Mohammed Ahmed Mahmoud, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03355716     History of Changes
Other Study ID Numbers: post-oprative pain relief
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

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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

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Ketamine
Fentanyl
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia