Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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.

Official Title
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Intraperitoneal Instillation of Bupivacaine With Either Magnesium Sulphate or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy: a Prospective, Randomized, Double-blinded Trial.

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Bupivacaine 0.25%
* Drug: Magnesium sulphate.
* Drug: nalbuphine


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group BM<br>bupivacaine 0.25% plus magnesium sulphate. | Drug: Bupivacaine 0.25%<br>* Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%<br>Drug: Magnesium sulphate.<br>* Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.<br>|
| Active Comparator: Group BN<br>bupivacaine 0.25% plus nalbuphine | Drug: Bupivacaine 0.25%<br>* Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%<br>Drug: nalbuphine<br>* Patients will receive intraperitoneal 5 mg nalbuphine<br>* Other names: opioid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue analgesia time | Time to first analgesia requirment(considering the extubation is the zero time) | First 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | First 24 hours postoperatively | 
| Total analgesic consumption | Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded. | First 24 hours postoperatively |