Comparison of Surgical Rectus Sheath Block and Intrathecal Morphine

NCT02790099 | Completed Phase 4

• 1 other identifier: UW 14-345
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective pain control. However, it is associated with significant side effects including nausea, vomiting and itchiness. Also, it is not suitable in all patients, for example, those with morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves injection of local anaesthetic agents into the rectus sheath space before closure of the wound. It has been shown to provide adequate pain control with less systemic side effects. The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and intrathecal morphine in post-Caesarean section pain control.

Conditions

Pain

Keywords

Pain; Postoperative pain control; Rectus sheath block; Intrathecal morphine; Caesarean section

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)

  at 12 hours postoperatively

Secondary Outcomes (7)

• Requirement of oral analgesics

  within 24hours postoperatively

• Time of mobilization

  3days postoperatively

• Side effect

  3days postoperatively

• Pain score

  Immediate postoperative

• Pain score

  4hours postoperatively

Study Arms (3)

Rectus sheath block only

EXPERIMENTAL

Patient will be given surgical rectus sheath block postoperatively with 40ml of bupivacaine (2.5mg/mL) and 0.1ml of normal saline will be injected intrathecally at time of spinal anaesthesia.

Drug: Bupivacaine

Intrathecal morphine group

ACTIVE COMPARATOR

0.1mg preservative free morphine will be injected intrathecally at time of spinal anesthesia and 40ml of normal saline will be injected as rectus sheath block.

Drug: Morphine

Both intervention

ACTIVE COMPARATOR

Patient will be given 0.1mg preservative free morphine intrathecally at time of spinal anaesthesia and surgical rectus sheath block with 40ml of bupivacaine (2.5mg/ml).

Drug: Bupivacaine; Drug: Morphine

Interventions

Bupivacaine DRUG

Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.

Also known as: Marcain

Both intervention; Rectus sheath block only

Morphine DRUG

0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia.

Both intervention; Intrathecal morphine group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for elective lower segment Caesarean section, using suprapubic transverse incision
• Willing and able to participate after the study has been explained
• Those understand either Cantonese, Putonghua or English

You may not qualify if:

• Patient with treatment for chronic pain
• History of narcotic abuse/ recreational drug use
• Allergy to opioids/ local anesthesia/ paracetamol/ tramadol/ non-steroidal anti-inflammatory drugs
• Patient with pre-eclampsia

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Department of Obstetrics and Gynaecology, Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (7)

• Uchiyama A, Nakano S, Ueyama H, Nishimura M, Tashiro C. Low dose intrathecal morphine and pain relief following caesarean section. Int J Obstet Anesth. 1994 Apr;3(2):87-91. doi: 10.1016/0959-289x(94)90175-9.

  PMID: 15636923 BACKGROUND

• Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.

  PMID: 10598635 BACKGROUND

• Sawi W, Choy YC. A comparative study of post operative analgesia, side effects profile and patient satisfaction using intrathecal fentanyl with and without morphine 0.1 mg in caesarean section. Middle East J Anaesthesiol. 2013 Feb;22(1):21-6.

  PMID: 23833846 BACKGROUND

• Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.

  PMID: 18428988 BACKGROUND

• Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner SC, Wanzel O, Kapral S. Ultrasonography-guided rectus sheath block in paediatric anaesthesia--a new approach to an old technique. Br J Anaesth. 2006 Aug;97(2):244-9. doi: 10.1093/bja/ael143. Epub 2006 Jun 23.

  PMID: 16798774 RESULT

• Niklasson B, Borjesson A, Carmnes UB, Segerdahl M, Ohman SG, Blanck A. Intraoperative injection of bupivacaine-adrenaline close to the fascia reduces morphine requirements after cesarean section: a randomized controlled trial. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1433-9. doi: 10.1111/j.1600-0412.2012.01480.x. Epub 2012 Nov 1.

  PMID: 22686512 RESULT

• Crosbie EJ, Massiah NS, Achiampong JY, Dolling S, Slade RJ. The surgical rectus sheath block for post-operative analgesia: a modern approach to an established technique. Eur J Obstet Gynecol Reprod Biol. 2012 Feb;160(2):196-200. doi: 10.1016/j.ejogrb.2011.10.015. Epub 2011 Nov 21.

  PMID: 22104479 RESULT

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; 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 Officials

• Ernest H. Y. Ng

  Queen Mary Hospital, Hong Kong

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 21, 2016
• First Posted: June 3, 2016
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)