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Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

intrathecal morphine

intrathecal saline

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

group I: morphine group

group II: control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Total postoperative analgesic consumption.

the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.

Secondary Outcome Measures

Visual analogue scale (VAS) scores

postoperative pain scores

Time to first request of rescue analgesia.

Tolerability as assessed by the incidence of side effects

the incidence of side effects

Full Information

NCT ID

NCT02731430

First Posted

April 3, 2016

Last Updated

April 6, 2016

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02731430

Brief Title

Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group I: morphine group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

group II: control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

intrathecal morphine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

intrathecal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Total postoperative analgesic consumption.

Description

the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.

Time Frame

24 hours postoperative

Secondary Outcome Measure Information:

Title

Visual analogue scale (VAS) scores

Description

postoperative pain scores

Time Frame

24 hours postoperative

Title

Time to first request of rescue analgesia.

Time Frame

24 hours postoperative

Title

Tolerability as assessed by the incidence of side effects

Description

the incidence of side effects

Time Frame

24 hours postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

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