Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

Postoperative Pain Clinical Trial

Official title:

Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02731430
• Other study ID #: 274
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: April 3, 2016
• Last updated: April 6, 2016
• Start date: December 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesia (ASA) II-III patients.

• Aged 30-50 years.

• The body mass index (BMI) of the patients needed to be over 40 kg/m² or over 35 kg/m² with at least one comorbidity.

Exclusion Criteria:

• Patients with a known allergy to the study drugs.

• Advanced cardiac, respiratory, renal or hepatic disease.

• Coagulation disorders.

• Infection at or near the site of intrathecal injection.

• Drug or alcohol abuse.

• Psychiatric illnesses that may interfere with perception and assessment of pain.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• intrathecal morphine
received 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
• intrathecal saline
received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative analgesic consumption.	the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.	24 hours postoperative	No
Secondary	Visual analogue scale (VAS) scores	postoperative pain scores	24 hours postoperative	No
Secondary	Time to first request of rescue analgesia.		24 hours postoperative	No
Secondary	Tolerability as assessed by the incidence of side effects	the incidence of side effects	24 hours postoperative	Yes