Comparison of Surgical Rectus Sheath Block and Intrathecal Morphine

Pain Clinical Trial

Official title:

Double-blinded Randomized Controlled Study for Comparison of Surgical Rectus Sheath and Intrathecal Morphine for Postoperative Pain Control After Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790099
• Other study ID #: UW 14-345
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2016
• Last updated: October 2, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Queen Mary Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The incidence of Caesarean section is increasing worldwide. Adequate post-operative analgesia is becoming an essential expectation of patients after Caesarean section. The process of recovery will be hindered by suboptimal pain control and eventually it will leads to immobilization and prolonged hospital stay.

Spinal anesthesia is usually the mode of anesthesia in pregnancy in view of increase general anesthetic risks. Intrathecal morphine can provide good pain control. However, pruritus can occur in up to 51% of patient, nausea and vomiting in up to 21%. Despite its significant side effects, there is an overall better patient satisfactory over use of intrathecal morphine. Due to its concern on respiratory depression, intrathecal morphine is not recommended in patients with severe respiratory disease, obstructive sleep apnoea or those receiving central nervous system depressants. As a result, there were numerous studies on alleviating the adverse effect and to search for other alternatives.

Rectus sheath block aims at blocking the terminal branches of 9th -12th intercostals nerve within the rectus sheath. They form rectus sheath plexus after piercing the posterior aspect of the rectus sheath and then branch into muscular and cutaneous branches. It can be given by anesthetist with or without ultrasound guidance. However, it involved additional time for administration of rectus sheath block and possibility of incorrect placement of catheter leading to ineffective analgesia.

On the contrary, surgical rectus sheath block was administrated by surgeon before closure of rectus sheath. It involves injection of local anesthetic in the rectus sheath space before closure of the wound under direct visual control. Surgical rectus sheath block was shown to be effective in postoperative pain control after transverse laparotomy in paediatrics patients. It was shown to be effective in postoperative pain control in Caesarean section without intrathecal morphine.

Surgical rectus sheath block may be a simple and safe alternative for intrathecal morphine. However, the evidence on its use in Obstetrics and Gynaecology was sparse and there is no study directly comparing the two different mode of analgesia. The aim of the study is to evaluate the use of surgical rectus sheath and intrathecal morphine for postoperative pain in Caesarean section; and its side effects profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Bupivacaine
Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.
• Morphine
0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia.

Locations

Country	Name	City	State
Hong Kong	Department of Obstetrics and Gynaecology, Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

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 — View Citation

Dahl JB, Jeppesen IS, Jørgensen H, Wetterslev J, Møiniche 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. Review. — View Citation

Niklasson B, Börjesson 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. 2 — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Willschke H, Bösenberg 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. Epub 2006 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Requirement of oral analgesics	Paracetamol 1gram four times a day on request basis will be prescribed. The number of time requiring paracetamol will be recorded. The need of additional analgesics will be recorded.	within 24hours postoperatively	No
Secondary	Time of mobilization	time of starting mobilization, defined as able to get out of bed without assistance	3days postoperatively	No
Secondary	Side effect	side effects including itchiness, nausea/ vomiting, sedation	3days postoperatively	Yes
Secondary	Pain score	Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10), will be accessed at the recovery room after the operation.	Immediate postoperative	No
Secondary	Pain score	Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)	4hours postoperatively	No
Secondary	Pain score	Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)	8hrs postoperatively	No
Secondary	Pain score	Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)	24hrs postoperatively	No