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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03393572

Enrollment

Registered

2018-01-08

Start date

2018-01-03

Completion date

2018-06-15

Last updated

2019-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

DRUGBupivacaine 0.25%

Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%

DRUGMagnesium sulphate.

Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.

DRUGnalbuphine

Patients will receive intraperitoneal 5 mg nalbuphine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 60 Years

Healthy volunteers

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,

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Visual analogue scale [VAS]	First 24 hours postoperatively	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	First 24 hours postoperatively	Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026