Back to resultsIntraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy
Primary Purpose
Anesthesia
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine 0.25%
Magnesium sulphate.
nalbuphine
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I and II
- scheduled for laparoscopic hysterectomy
Exclusion Criteria:
- ASA physical status more than II
- Obesity (body mass index higher than 30 kg/ m2)
- History of chronic opioids intake
- Known hypomagnesaemia or hypermagnesaemia
- Chronic alcoholism
- Heart block
- Renal failure
- Patients with history of left ventricular failure
- Patients taking beta-blocking drugs
- Allergy to the study drugs
- if surgery changed to open hysterectomy,
Sites / Locations
- Marwa Elbeialy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group BM
Group BN
Arm Description
bupivacaine 0.25% plus magnesium sulphate.
bupivacaine 0.25% plus nalbuphine
Outcomes
Primary Outcome Measures
Rescue analgesia time
Time to first analgesia requirment(considering the extubation is the zero time)
Secondary Outcome Measures
Visual analogue scale [VAS]
Visual analogue scale [VAS] will be used to measure pain score at 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 h after surgery. All the study patients will be instructed about the use of the VAS scale before induction of anesthesia (VAS score 0 cm = no pain, VAS score 10 cm = worst possible pain)
Total analgesic consumption
Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03393572
Brief Title
Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy
Official Title
Intraperitoneal Instillation of Bupivacaine With Either Magnesium Sulphate or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy: a Prospective, Randomized, Double-blinded Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group BM
Arm Type
Active Comparator
Arm Description
bupivacaine 0.25% plus magnesium sulphate.
Arm Title
Group BN
Arm Type
Active Comparator
Arm Description
bupivacaine 0.25% plus nalbuphine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25%
Intervention Description
Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%
Intervention Type
Drug
Intervention Name(s)
Magnesium sulphate.
Intervention Description
Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.
Intervention Type
Drug
Intervention Name(s)
nalbuphine
Other Intervention Name(s)
opioid
Intervention Description
Patients will receive intraperitoneal 5 mg nalbuphine
Primary Outcome Measure Information:
Title
Rescue analgesia time
Description
Time to first analgesia requirment(considering the extubation is the zero time)
Time Frame
First 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Visual analogue scale [VAS]
Description
Visual analogue scale [VAS] will be used to measure pain score at 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 h after surgery. All the study patients will be instructed about the use of the VAS scale before induction of anesthesia (VAS score 0 cm = no pain, VAS score 10 cm = worst possible pain)
Time Frame
First 24 hours postoperatively
Title
Total analgesic consumption
Description
Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded.
Time Frame
First 24 hours postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status I and II
scheduled for laparoscopic hysterectomy
Exclusion Criteria:
ASA physical status more than II
Obesity (body mass index higher than 30 kg/ m2)
History of chronic opioids intake
Known hypomagnesaemia or hypermagnesaemia
Chronic alcoholism
Heart block
Renal failure
Patients with history of left ventricular failure
Patients taking beta-blocking drugs
Allergy to the study drugs
if surgery changed to open hysterectomy,
Facility Information:
Facility Name
Marwa Elbeialy
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
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Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy
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