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Clinical Trials/NCT02790099
NCT02790099
Completed
Phase 4

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

Queen Mary Hospital, Hong Kong1 site in 1 country144 target enrollmentSeptember 2014
ConditionsPain
InterventionsBupivacaineMorphine

Overview

Phase
Phase 4
Intervention
Bupivacaine
Conditions
Pain
Sponsor
Queen Mary Hospital, Hong Kong
Enrollment
144
Locations
1
Primary Endpoint
Pain score
Status
Completed
Last Updated
9 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Queen Mary Hospital, Hong Kong
Responsible Party
Principal Investigator
Principal Investigator

Lui Man Wa

Dr

Queen Mary Hospital, Hong Kong

Eligibility Criteria

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

Arms & Interventions

Rectus sheath block only

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.

Intervention: Bupivacaine

Intrathecal morphine group

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.

Intervention: Morphine

Both intervention

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).

Intervention: Bupivacaine

Both intervention

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).

Intervention: Morphine

Outcomes

Primary Outcomes

Pain score

Time Frame: at 12 hours postoperatively

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

Secondary Outcomes

  • Side effect(3days postoperatively)
  • Requirement of oral analgesics(within 24hours postoperatively)
  • Time of mobilization(3days postoperatively)
  • Pain score(24hrs postoperatively)

Study Sites (1)

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