Analgesic Efficacy of Different Nerve Blocks in Postoperative Cesarean Section

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06088420
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

comparing analgesic efficacy of different nerve blocks on post operative cesarean sections.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Drug: intrathecal morphine for intrathecal morphine group . bupivacaine 0.25% for Quadratus Lumborum and Erector Spinae nerve block groups .	N/A

Detailed Description

Analgesic efficacy of Erector Spinae, Quadratus Lumborum and Intrathecal Morphine for post operative pain relief after cesarean section, A Prospective Randomized Single-Blind Controlled Study.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Analgesic Efficacy of Erector Spinae Block , Quadratus Lumborum Block and Intrathecal Morphine for Post Operative Pain Relief After Cesarean Section, A Prospective Randomized Single-Blind Controlled Study
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intrathcal Morphine Group Intrathecal morphine administration for post operative pain relief after cesarean section	Drug: intrathecal morphine for intrathecal morphine group . bupivacaine 0.25% for Quadratus Lumborum and Erector Spinae nerve block groups .; Intrathecal morphine Group: All members of this group will receive spinal anesthesia with 12 mg 0.5% (2.2ml) hyperbaric bupivicane with intrathecal morphine(100mcg). QLB Group: All members of this group will receive bilateral quadratus lumborum block after spinal anesthesia at end of operation. The QLB will be performed by using bupivacaine 0.25% .ESB Group: All members of this group will receive bilateral erector spinae block after spinal anesthesia at end of operation. The ESB will be performed by using bupivacaine 0.25% (15 ml in each side) .
Active Comparator: Quadratus Lumborum nerve block group Quadratus Lumborum nerve block administration for post operative pain relief after cesarean section	Drug: intrathecal morphine for intrathecal morphine group . bupivacaine 0.25% for Quadratus Lumborum and Erector Spinae nerve block groups .; Intrathecal morphine Group: All members of this group will receive spinal anesthesia with 12 mg 0.5% (2.2ml) hyperbaric bupivicane with intrathecal morphine(100mcg). QLB Group: All members of this group will receive bilateral quadratus lumborum block after spinal anesthesia at end of operation. The QLB will be performed by using bupivacaine 0.25% .ESB Group: All members of this group will receive bilateral erector spinae block after spinal anesthesia at end of operation. The ESB will be performed by using bupivacaine 0.25% (15 ml in each side) .
Active Comparator: Erector Spinae nerve block group Erector Spinae nerve block administraion for post operative pain relief after cesarean section	Drug: intrathecal morphine for intrathecal morphine group . bupivacaine 0.25% for Quadratus Lumborum and Erector Spinae nerve block groups .; Intrathecal morphine Group: All members of this group will receive spinal anesthesia with 12 mg 0.5% (2.2ml) hyperbaric bupivicane with intrathecal morphine(100mcg). QLB Group: All members of this group will receive bilateral quadratus lumborum block after spinal anesthesia at end of operation. The QLB will be performed by using bupivacaine 0.25% .ESB Group: All members of this group will receive bilateral erector spinae block after spinal anesthesia at end of operation. The ESB will be performed by using bupivacaine 0.25% (15 ml in each side) .

Outcome Measures

Primary Outcome Measures

1. Duration of analgesia until first analgesic request. [24 hours .]

   post operative pain control.

Secondary Outcome Measures

1. onset of pain . pain intensity using Numerical Analogue Score ( NRS) . ordered from 0 to 10 . 0 value indicates no pain , 10 value indicates worst pain [more or less than 2 years]

   post operative pain control.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-40 years old

• more or equal 37 weeks of gestation

• ASA 1,2

• Elective cesarean delivery

Exclusion Criteria:

• Patient refusal

• inability to cooperate with or understand the study

• local infection.

• bleeding disorder

• known anaphylaxis to any drug used in the trial

• ASA physical status more than 2

• emergency operations

• chronic opioid use (opioid use in the past 3 months)

• Neurologic deficit or disorder

• contraindication to regional anesthesia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mahmoud Mamdouh Ekram	Assiut	Manfalout	Egypt

Sponsors and Collaborators

• Assiut University

Investigators

• Study Director: dr. Hoha Hassan, lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud Mamdouh Ekram, principal investigator., Assiut University
• ClinicalTrials.gov Identifier: NCT06088420
• Other Study ID Numbers: 17101962
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Morphine; Bupivacaine

Study Results

No Results Posted as of Oct 18, 2023