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Post-operative Pain Relief in Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bupivacaine
morphine
fentanyl
Ketamine:
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

22 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group A (placebo):

    Group B

    Group C

    Group D

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    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) .

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2017
    Last Updated
    November 27, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03355716
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    March 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (placebo):
    Arm Type
    Placebo Comparator
    Arm Description
    instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)
    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm Description
    Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)
    Arm Title
    Group D
    Arm Type
    Active Comparator
    Arm Description
    Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine
    Intervention Description
    Bupivacaine 25 ml (0.25%)
    Intervention Type
    Drug
    Intervention Name(s)
    morphine
    Intervention Description
    Morphine (3.0 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    fentanyl
    Intervention Description
    fentanyl (30.0 Mc)
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine:
    Intervention Description
    ketamine (0.5 mg/kg).
    Primary Outcome Measure Information:
    Title
    post operative pain
    Description
    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) .
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed Ahmed Mahmoud
    Phone
    0108834312
    Email
    dr_m_hamouda@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    abualauon Mohamed Abedalmohsen
    Phone
    01006253939

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26957685
    Citation
    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.
    Results Reference
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    Post-operative Pain Relief in Laparoscopic Cholecystectomy

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