Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section

NCT03451695 | Completed Phase 4

• 1 other identifier: IRC/1183/017
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of chronic post-surgical pain (CPSP) after caesarean section (CS) is reported to be as high as 18%, reflecting it to be a significant clinical problem. Studies related to prevention of progression of acute post-CS pain to its chronicity are sparse. Current guidelines on post-CS analgesia recommend the use of intrathecal (IT) opioids to spinal anaesthesia for improved post-CS pain relief. Despite its frequent use, studies related to the IT morphine use and its association with post-CS chronic pain are lacking. A recent prospective observation study revealed a significant reduction in persistent pain after CS when IT morphine was used as an adjuvant to spinal anaesthesia. However, there is no any randomized controlled trial (RCT) that has explored this association to date. We hypothesized that spinal morphine would reduce the incidence of persistent pain after CS.

Conditions

Chronic Pain Post-Procedural

Outcome Measures

Primary Outcomes (1)

• Number of participants with the incidence of post surgery chronic pain at 3 months following elective caesarean section

  To find the number of participants with the incidence of post surgery chronic pain at 3 months following elective caesarean section in those receiving Intrathecal morphine and normal saline

  3 months after elective caesarean section

Secondary Outcomes (5)

• Number of participants with the incidence of post surgery chronic pain at 6 months following elective caesarean section

  6 month after elective caesarean section

• Brief pain inventory (BPI) pain severity scores at 3 and 6 month after elective caesarean section between those receiving intrathecal morphine and normal saline

  3 and 6 months after elective caesarean section

• Brief Pain Inventory (BPI) pain interference scores at 3 and 6 month after elective caesarean section between those receiving intrathecal morphine and normal saline

  3 and 6 months after elective caesarean section

• Any pain medication or treatment received for relieving pain. If so, the amount of pain relieved.

  3 and 6 months after elective caesarean section

• Numerical rating Scale (NRS) pain scores and opioid consumption post operatively

  24 and 48 hrs after surgery

Study Arms (2)

Morphine group

EXPERIMENTAL

Morphine group will receive intrathecal 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 μg of fentanyl (0.2 ml) and 100 μg of preservative free morphine (0.1 ml).

Drug: Morphine

Placebo group

PLACEBO COMPARATOR

Placebo group will receive intrathecal 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 μg of fentanyl (0.2 ml) and normal saline (0.1 ml).

Drug: Placebo

Interventions

Morphine DRUG

Morphine group will receive intrathecal 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 μg of fentanyl (0.2 ml) and 100 μg of preservative free morphine (0.1 ml).

Morphine group

Placebo DRUG

Placebo group will receive 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 μg of fentanyl (0.2 ml) and normal saline (0.1ml)

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Woman in American Society of Anesthesiologists (ASA) physical status classification II with full-term singleton pregnancy undergoing planned CS under spinal anesthesia.

You may not qualify if:

• contraindication to spinal anaesthesia, height\<150 cm, ASA \> II, BMI\> 40, allergy to any drug used in the study, recent opioid exposure, substance abuse, significant cardiovascular, renal, or hepatic disease; and known fetal abnormalities.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, 56700, Nepal

Location

Related Publications (1)

• Subedi A, Schyns-van den Berg AMJV, Thapa P, Limbu PM, Trikhatri Y, Poudel A, Dhakal Y, Bhandari S. Intrathecal morphine does not prevent chronic postsurgical pain after elective Caesarean delivery: a randomised controlled trial. Br J Anaesth. 2022 Apr;128(4):700-707. doi: 10.1016/j.bja.2021.11.036. Epub 2022 Jan 26.

  PMID: 35090722 DERIVED

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 2, 2018
• Study Start: April 1, 2018
• Primary Completion: December 26, 2020
• Study Completion: March 30, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The final research data and study protocol will be shared with the journal accepting the article for publication. It will be available simultaneously after publication of the article.
• Access Criteria: The IPD may be accessed from the link provided in the published manuscript The IPD may also be shared to other researchers by the investigators upon request

Locations

NE (1)